MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-05 for FORCEPS P761-6 120MM CVD HALSTEAD manufactured by Integra Microfrance S.a.s..
[92475731]
Integra has completed their internal investigation on october 25, 2017. Results: evaluation of returned device; the forceps are broken at section change at hinge. The fragment were returned. A corroded area can be observed within the fracture zone. It suggests the presence of a crack prior to the breakage. A thorough observation of the breakage area did not reveal manufacturing or material defect. Dhr review; no non-conformity related to this issue for this lot. Complaints history; no adverse trend. Conclusion: considering that no material or manufacturing defect was found and that there are evidences of a crack prior to the breakage, the most probable cause of this rupture is the recurrence of impacts on the instrument during its use, which weakened the forceps arm and progressively led to the reported event. Moreover, the ifu provided with the device requires to: "check the condition of instruments before and after each case. Remove from use any incomplete or poorly operation instruments".
Patient Sequence No: 1, Text Type: N, H10
[92475732]
It was reported that the jaw of the forceps broke. Product was in contact with the patient; however, no patient injury was reported and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00128 |
| MDR Report Key | 7002338 |
| Date Received | 2017-11-05 |
| Date of Report | 2017-10-17 |
| Date Mfgr Received | 2017-10-17 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2017-11-05 |
| 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 | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FORCEPS P761-6 120MM CVD HALSTEAD |
| Generic Name | PFM11 |
| Product Code | GEN |
| Date Received | 2017-11-05 |
| Returned To Mfg | 2017-10-17 |
| Catalog Number | P761-6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-05 |