MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-12-10 for SCISSORS,UNKNOWN XXX-SCISSORS manufactured by Integra Microfrance S.a.s..
[129876201]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[129876202]
It was reported that in (b)(6) 2017, during an unspecified laparoscopy, the metzenbaum scissors was used and a chisel broke inside the patient and a metal part/tip was left in the patient. It was reported that the metal part is not from the blade of the scissors, but from the articulated hinge part of the scissor tip. It is unknown if there was any patient injury or a surgical delay. Additional information was received on (b)(6) 2018 stated lot number 308676 corresponds to a tube, cev649-5b dia 5mm 350mm (concomitant product). Additional request for information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00177 |
| MDR Report Key | 8148941 |
| Report Source | FOREIGN |
| Date Received | 2018-12-10 |
| Date of Report | 2018-11-21 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-12-10 |
| 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 KIMBERLY SHELLY |
| 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 | 3 |
| Brand Name | SCISSORS,UNKNOWN |
| Generic Name | SCISSORS |
| Product Code | LRW |
| Date Received | 2018-12-10 |
| Catalog Number | XXX-SCISSORS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-10 |