MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for MICRO NDLHLDR DIAM.COATED180MM STR FD258R manufactured by Aesculap Ag.
[139338492]
(b)(4). Investigation: failure description: the needle holder is in a heavily used condition, several stains and points of corrosion can be found all over the surface. Also the working end is coated in black. A pictorial documentation was visually and microscopically carried out. Several signs of wear and tear, stains and corrosion can be found all over the surface. The working end including the coating in the jaw is worn. The working end of the provided needle holder is coated black and the screw has not the same color as the area around. In the screw slot, remains of a gold colored coating can be found. This is not according to the aesculap specifications; we assume this is from a third party maintenance. A stamp of the aesculap technical service cannot be found on the instrument. Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to wear and tear. Associated medwatches: 9610612-2019-00114; 9610612-2019-00115; 9610612-2019-00116; 9610612-2019-00117.
Patient Sequence No: 1, Text Type: N, H10
[139338493]
It was reported that intraoperatively the diamant coating comes off the instrument. It was reported that the needle holders (5) are losing the diamant coatings due to abrasion in the area of the branches (area where suture and needle is catches); this was noticed at the end of 2018. Five needle holders were effected-one will be send for evaluation. Per the surgeon, it seems to be a sign at the abrasion and not the whole coating coming off at the same time. The surgeon does not think that bigger particles have gotten into the wound. Micro particles in the form of abrasion are sure to be there already, since the signs of abrasion have only occurred in the area where the needle and thread are gripped. It was reported, the surgeon considers it is unlikely that the coating will came off during the sterilization process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00113 |
| MDR Report Key | 8366915 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date Facility Aware | 2019-02-12 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2015-03-09 |
| Date Added to Maude | 2019-02-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer Street | PO 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 | 0 |
| Brand Name | MICRO NDLHLDR DIAM.COATED180MM STR |
| Generic Name | IMPLANTOLOGY: MICRO INSTRUMENT |
| Product Code | DZN |
| Date Received | 2019-02-25 |
| Returned To Mfg | 2019-02-07 |
| Model Number | FD258R |
| Catalog Number | FD258R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-25 |