MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-07 for JAMESON TENOTOMY SCISSDELCVDB/B150MM BC177R manufactured by Aesculap Ag.
[144969507]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
Patient Sequence No: 1, Text Type: N, H10
[144969508]
It was reported that there was an issue with the tenotomy scissors. During surgery, the scissors was noted to have pitting. This was viewed under the microscope and they were being used the first time. No additional intervention was required and there was no patient harm. There may have been a short delay in surgery. Another pair of scissors was used instead. Additional information was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00310 |
| MDR Report Key | 8587962 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-07 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-04-12 |
| Date Facility Aware | 2019-04-30 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2018-08-16 |
| Date Added to Maude | 2019-05-07 |
| 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 | MS. KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, MO 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | JAMESON TENOTOMY SCISSDELCVDB/B150MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | LRW |
| Date Received | 2019-05-07 |
| Returned To Mfg | 2019-04-26 |
| Model Number | BC177R |
| Catalog Number | BC177R |
| Lot Number | 4509839109 |
| 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 | 2019-05-07 |