MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-21 for LITTLER SCISSORS W/EYE CVD 115MM BC163R manufactured by Aesculap Ag.
[136793008]
Manufacturing site evaluation: ongoing. If additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136793009]
It was reported a piece of clamp broke off intraoperatively. During a hysterectomy a piece of an instrument broke off while being used. There was a delay in surgery as the tip had to be retrieved after breaking off. An x-ray was used for the retrieval. Both parts were retrieved with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00107 |
| MDR Report Key | 8359444 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-21 |
| Date of Report | 2019-04-03 |
| Date Facility Aware | 2019-03-28 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-02-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI MO 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| 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 | LITTLER SCISSORS W/EYE CVD 115MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | LRW |
| Date Received | 2019-02-21 |
| Model Number | BC163R |
| Catalog Number | BC163R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-02-21 |