MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-10-15 for TC DE'BAKEY NEEDLE HOLDERDELSERR165MM BM033R manufactured by Aesculap Ag & Co. Kg.
[20753442]
Country of complaint: (b)(6). At the end of a hernia surgery, when closing the incision, the needle dropped. After checking, it was found that one tip of the needle holder fractured and the fractured parts were missing. For 2 hours the surgeon and nurse made attempts to locate the missing part using magnet and c-arm x-ray machine; the missing piece was not found. Surgeon had to close incision and end the surgery and was not for sure if the broken part remained in the patient. Patient's hospitalization was prolonged.
Patient Sequence No: 1, Text Type: D, B5
[20945480]
Manufactring site evaluation: waiting for product return.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00786 |
| MDR Report Key | 4269446 |
| Report Source | 01,07 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-10-08 |
| Date of Event | 2014-07-08 |
| Date Mfgr Received | 2014-09-12 |
| Date Added to Maude | 2014-11-25 |
| 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 POINT DEIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG&CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLILNGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC DE'BAKEY NEEDLE HOLDERDELSERR165MM |
| Product Code | HXK |
| Date Received | 2014-10-15 |
| Model Number | BM033R |
| Catalog Number | BM033R |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-15 |