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 2017-01-04 for CNO12, GELPOINT PATH 9CM CNO11 101351501 manufactured by Applied Medical Resources.
[63916353]
The incident device is anticipated to return. A follow-up report will be provided upon completion of 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. There is no report of serious injury or death associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[63916354]
On tamis procedure - "inner lumen of gelpoint path trocar dislodged - surgeon did not removed from patient immediately and proceeded with case. Surgeon suggested this may have resulted from the diathermy tip, as the instrument was brand new. The surgeon completed multiple exchanges and it is thought he stabbed inner lumen with the diathermy tip and dragged internals of the trocar through. Photo's to be emailed separately. " patient status - no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[75879244]
The event unit was returned to applied medical for evaluation. Upon investigation, engineering confirmed that the shield, an internal component of the seal, had dislodged from one of the trocar sleeves. The shield was visually inspected and scratches and marks were observed on the dislodged shield. It is likely that the trocar shield was dislodged by an instrument that was used during the procedure. Based on the damage that was observed on the dislodged shield, it is likely that an instrument caught on the shield during insertion and dislodged it from the trocar sleeve. The instructions for use (ifu) states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers", and "all instruments should be centered axially when inserted through the seal". Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2017-00006 |
| MDR Report Key | 6223878 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-04 |
| Date of Report | 2017-12-05 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2016-12-13 |
| Date Added to Maude | 2017-01-04 |
| 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 Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO12, GELPOINT PATH 9CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2017-01-04 |
| Returned To Mfg | 2017-01-31 |
| Model Number | CNO11 |
| Catalog Number | 101351501 |
| Lot Number | UNK |
| Device Availability | R |
| 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 | 2017-01-04 |