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.
[3556326]
Country of complaint: (b)(6). Tip of needle holder broke during surgery. According to the assisting nurse the fragment of the tip fell into the pt but could be found without any time delay, no consequences for the pt. The fragment was scrapped.
Patient Sequence No: 1, Text Type: D, B5
[10818211]
Evaluation: instrument was repaired at ats (de) in 2013. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2013-00039 |
| MDR Report Key | 3196790 |
| Report Source | 01,07 |
| Date Received | 2013-06-25 |
| Date of Report | 2013-05-22 |
| Date Mfgr Received | 2013-04-11 |
| 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 | 2013-04-16 |
| 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, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-25 |