MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-06-10 for TC MAYO HEGAR NDL HOLDERHVYSERR205MM BM067R manufactured by Aesculap Ag & Co. Kg.
[5932226]
Tip of tc insert broke during c-section operation. No pt injury. Surgery delay 40-45 mins. Broken tip was retrieved with direct visualization, x-ray used to confirm no fragments remained. The broken piece of the tip will not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[13353300]
Manufacturing site evaluation: investigation on-going.
Patient Sequence No: 1, Text Type: N, H10
[35325928]
(b)(4). Manufacturing site evaluation: the tip of the carbide metal insert of the received device is broken off. The instrument was analyzed with the digital microscope (b)(4) by keyence. Hardness was tested with hardness tester vickers hv 5, ident no. 30077. Carbide metal - target:1150 +-50 hv , actual: 1180 hv. Basic material - target: 420 +110 hv , actual: 505 hv. The hardness is according to the specifications. It is assumed that the user tried to grasp a needle with the tips of the needle holder as the needle slipped and caused the breakage; however this is not confirmed. The damage is likely user related. Corrective / preventive action(s) is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00480 |
| MDR Report Key | 4845224 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-06-10 |
| Date of Report | 2015-12-30 |
| Date Mfgr Received | 2015-05-12 |
| Date Added to Maude | 2015-06-24 |
| 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 AG & CO KG |
| Manufacturer Street | P.O. 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 | 3 |
| Brand Name | TC MAYO HEGAR NDL HOLDERHVYSERR205MM |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2015-06-10 |
| Model Number | BM067R |
| Catalog Number | BM067R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-10 |