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 2015-08-21 for TC MAYO-HEGAR NDL HOLDERHVYSERR205MM BM067R manufactured by Aesculap, Inc..
[24246271]
Us reporting agent notified on: (b)(6) 2015. Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[24246272]
Country of complaint: (b)(6). Loss of a piece of the jaws of the needle holder in the surgical site during the intervention. The broken piece was recovered.
Patient Sequence No: 1, Text Type: D, B5
[38859372]
(b)(4). Manufacturing site evaluation: samples received: 1 bm067r mayo-hegar needle holder. An investigation was performed visually. The metal inlay of one jaw was broken off and was not returned for evaluation. The broken segment is approximately 2 mm from the tip of the jaw. The labeling of the instrument was not completed by aesculap. Also the solder joint is not to aesculap standards. The device appears to have been repaired by a foreign company and does not meet aesculap standards. Final conclusion: complaint is not justified. The failure result is user related, using non authorized repair service. Corrective/preventive actions: not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00730 |
| MDR Report Key | 5032865 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-21 |
| Date of Report | 2016-02-23 |
| Date of Event | 2015-06-03 |
| Date Mfgr Received | 2015-07-22 |
| Date Added to Maude | 2015-08-26 |
| 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, INC. |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN 75801 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC MAYO-HEGAR NDL HOLDERHVYSERR205MM |
| Product Code | HXK |
| Date Received | 2015-08-21 |
| Model Number | BM067R |
| Catalog Number | BM067R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-21 |