MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-25 for TC BABY-CRILE-WOOD NDL HLDR SERR 150MM BM013R manufactured by Aesculap Ag & Co Kg.
[17928798]
Country of complaint: (b)(6). The tip of the needle holder broke off intraoperatively. The possibility, that the tip fell into the pt cannot be ruled out.
Patient Sequence No: 1, Text Type: D, B5
[18153767]
Evaluation: needle holders which have been repaired, show a little bigger tendency to break than brand new ones, if the carbide metal was changed. This problem is well known to us. But nevertheless even the strength of a repaired needle holder is strong enough to last with proper handling. Whether the handling was improper or not cannot be ascertained. It concerns a forced fracture caused by a mechanical overload situation. Despite several requests we did not receive info regarding the pt's condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2013-00040 |
| MDR Report Key | 3196805 |
| Report Source | 01,07 |
| Date Received | 2013-06-25 |
| Date of Report | 2013-05-22 |
| Date Mfgr Received | 2013-03-21 |
| Date Added to Maude | 2013-09-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P. O. BOX 40 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC BABY-CRILE-WOOD NDL HLDR SERR 150MM |
| Product Code | HXK |
| Date Received | 2013-06-25 |
| Returned To Mfg | 2013-03-27 |
| Model Number | BM013R |
| Catalog Number | BM013R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO KG |
| Manufacturer Address | TUTTLINGEN 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-25 |