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 2019-02-05 for TC BABY-METZ SCISSORSDELCVDB/B145MM BC259R manufactured by Aesculap Ag.
[137006759]
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[137006760]
It was reported that there was an intraoperative issue with the scissors during a procedure for carpal tunnel syndrome. It broke suddenly during normal use and without unusual circumstances or force. The tissue was being spread using the baby metz scissors when the malfunction occurred; one of the sides of the handle broke off near the joint. The surgical outcome and patient data was not provided. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00053 |
| MDR Report Key | 8306579 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-06 |
| Date Facility Aware | 2019-02-06 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-02-05 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC BABY-METZ SCISSORSDELCVDB/B145MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | LRW |
| Date Received | 2019-02-05 |
| Returned To Mfg | 2019-01-18 |
| Model Number | BC259R |
| Catalog Number | BC259R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |