MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for TC WIRE HOLDING FORCEPS LAT-JAW 170MM LX176R manufactured by Aesculap Ag.
[142930600]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[142930601]
It was reported that there was an issue with the tc wire holding forceps. The customer stated that two products were received and rejected. The cracks were identified at the facility upon receipt and the forceps were not used; a picture revealed fractures on the inserts. There was no patient involvement or procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00293 |
| MDR Report Key | 8541699 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-03 |
| Date Facility Aware | 2019-04-17 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2018-12-22 |
| Date Added to Maude | 2019-04-23 |
| 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. 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 | 0 |
| Brand Name | TC WIRE HOLDING FORCEPS LAT-JAW 170MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | HYA |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-04-12 |
| Model Number | LX176R |
| Catalog Number | LX176R |
| Lot Number | 4510089589 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 102 DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-04-23 |