MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-05-19 for FORCEPS CEV134 BIPOLAR 350MM MOUIEL manufactured by Integra Microfrance S.a.s..
[5817605]
Customer initially reports that the device stopped working during a bariatric surgery. The patient has a hematoma. The patient was treated with surgicel and hematoma drainage. The surgeon finished the surgery by using the forceps in monopolar mode on (b)(6) 2015. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[13333547]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
[60908579]
On (b)(6) 2015, integra investigation completed. Method, failure analysis, device history evaluation results: failure analysis - the instrument was not returned. The investigation could not be done. Device history evaluation - unknown lot number impossible to do the dhr review. Conclusion: it is impossible to confirm the complaint and to find the root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00024 |
| MDR Report Key | 4788050 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-05-19 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-05-04 |
| Date Added to Maude | 2015-05-22 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Country | US |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS CEV134 BIPOLAR 350MM MOUIEL |
| Generic Name | PFM16 |
| Product Code | HIN |
| Date Received | 2015-05-19 |
| Catalog Number | CEV134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-19 |