MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-27 for MAYO SCISSORS CVD 6 3/4" BEV 141317 manufactured by Teleflex Medical.
[176423929]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[176423930]
It was reported that the surgeon was doing a hip surgery and was cutting near the fascia around acetabulum and the next thing the scissors were in three pieces per the scrub nurse. They then stopped the surgery, did an x-ray, and then general surgery removed the piece still in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2020-00049 |
| MDR Report Key | 9632350 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-01-27 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYO SCISSORS CVD 6 3/4" BEV |
| Generic Name | SCISSORS, GENERAL, SURGICAL |
| Product Code | LRW |
| Date Received | 2020-01-27 |
| Returned To Mfg | 2020-01-17 |
| Catalog Number | 141317 |
| Lot Number | XX8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-27 |