MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-21 for CNO11, GELPOINT PATH 5.5CM 18 manufactured by Applied Medical Resources.
[47894604]
The incident device is anticipated to return. A follow-up report will be provided upon completion of the investigation. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[47894665]
Parastomal hernia and proctectomy - "the gel point path was used with 1 x low profile z-thread and the 2 sleeves/ trocars present in the package. Around 3 hours into the procedure (after multiple movement/ migration of the z-thread due to scope cleaning) the z-thread completely came out of the gel along with the camera. Mr (b)(6) reinserted the port immediately. 10-15 minutes later it was apparent (due to the noise) that a gas leak was present. There seemed to be a slight tear/rip in the gel which was visible to the eye. The gas leak from the tear progressively got worse, making a 'bubbling effect' on one occasion. At the end of the procedure when suction irrigation was used, fluid was 'oozing' from the tear site. The incident did not affect the procedure outcome. " additional information received via email june 14, 2016: "question from clinical development: also would be good to know if dr. (b)(6) reinserted the z-thread in the same hole as before or in a new placement in the gel: "my initial reaction would be no he did not (as the hole which gas was leaking out of was slightly above the z-thread trocar). " patient status- "healthy. "
Patient Sequence No: 1, Text Type: D, B5
[57959704]
Investigation summary: one (1) gelseal cap, four (4) 10mm trocar sleeves, one (1) access channel, one (1) introducer, and one (1) obturator were returned for evaluation. Upon visual inspection, engineering observed sleeve insertions at three different sites on the gelseal cap. However, two of these had multiple through holes, showing that the sleeve had been removed and reinserted. No damages or defects were noted on the four trocar sleeves, access channel, introducer, and obturator. A leak test was conducted and engineering noted leaking sounds from one of the three sites that showed multiple sleeve insertions. Engineering confirmed the "bubbling effect" observed during the event. The root cause of the "bubbling effect" is most likely due to multiple attempts of migration and placement of the sleeves. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[69776131]
Investigation summary: one (1) gelseal cap, four (4) 10 mm trocar sleeves, one (1) access channel, one (1) introducer, and one (1) obturator were returned for evaluation. Upon visual inspection, engineering observed sleeve insertions at three different sites on the gelseal cap. However, two of these had multiple through holes, showing that the sleeve had been removed and reinserted. No damages or defects were noted on the four trocar sleeves, access channel, introducer, and obturator. A leak test was conducted and engineering noted leaking sounds from one of the three sites that showed multiple sleeve insertions. Engineering confirmed the "bubbling effect" observed during the event. The root cause of the "bubbling effect" is most likely due to multiple attempts of migration and placement of the sleeves. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016. This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter. Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes. The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies). This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.
Patient Sequence No: 1, Text Type: N, H10
[69776132]
Procedure performed unknown - "the gel point path was used with 1 x low profile z-thread and the 2 sleeves/ trocars present in the package. Around 3 hours into the procedure (after multiple movement/ migration of the z-thread due to scope cleaning) the z-thread completely came out of the gel along with the camera. Mr (b)(6) reinserted the port immediately. 10-15 minutes later it was apparent (due to the noise) that a gas leak was present. There seemed to be a slight tear/rip in the gel which was visible to the eye. The gas leak from the tear progressively got worse, making a 'bubbling effect' on one occasion. At the end of the procedure when suction irrigation was used, fluid was 'oozing' from the tear site. The incident did not affect the procedure outcome. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2016-00457 |
| MDR Report Key | 5740229 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-21 |
| Date of Report | 2017-03-08 |
| Date of Event | 2016-05-24 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2016-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO11, GELPOINT PATH 5.5CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2016-06-21 |
| Returned To Mfg | 2016-06-27 |
| Model Number | 18 |
| Catalog Number | 18 |
| Lot Number | 1263321 |
| Device Expiration Date | 2019-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-21 |