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 2016-07-07 for CNO11, GELPOINT PATH 5.5CM 101424301 manufactured by Applied Medical Resources.
[49029953]
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.
Patient Sequence No: 1, Text Type: N, H10
[49029954]
Ta tme, practicing purse-string during ta tme workshop in lap-trainer in human colon- "during the purse-string exercise for ta tme at the ta tme workshop at (b)(6) center the delegate and faculty member spotted the plastic ring in the human colon ( in the lap-trainer) when they pulled the camera back. The plastic ring came out of the trocar that was used for a hand-instrument. The trocar has not been used for the scope. " patient status: n/a.
Patient Sequence No: 1, Text Type: D, B5
[49044089]
Patient Sequence No: 1, Text Type: N, H10
[56175729]
Investigation summary: one (1) 10mm trocar sleeve was returned for evaluation. Upon visual inspection, engineering confirmed that the shield was fully dislodged from the seal of the trocar. Upon further inspection, engineering disassembled the 10mm sleeve and found that the septum and duckbill were torn. Two tears were found near the bottom opening of the septum and one tear was found on the bottom edge of the duckbill. All gelpoint? Minis undergo 100% visual inspection during the assembly and packaging process. The most likely root cause of the shield dislodging would be inserting an instrument non-axially into the sleeve. There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices. The instructions for use (ifu) warns "extra care should be used when inserting angular and asymmetrical instruments... To minimize eversion of the sleeve's seal, instruments with high textured surfaces should be coated with a sterile lubricant. " although the root cause of the event could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. Additional information requested and received. 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
| Report Number | 2027111-2016-00515 |
| MDR Report Key | 5777499 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-09 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-09-30 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2016-07-07 |
| 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 | CNO11, GELPOINT PATH 5.5CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2016-07-07 |
| Returned To Mfg | 2016-07-01 |
| Model Number | CNO11 |
| Catalog Number | 101424301 |
| Lot Number | 1265864 |
| Device Expiration Date | 2019-03-02 |
| 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 | 2016-07-07 |