MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-22 for SUSI MAYO-HEGAR NEEDLEHOLDER 150MM BM235SU manufactured by Aesculap Ag.
[133752022]
(b)(4). When additional information is received a follow up report will be submitted. The device quality and manufacturing history records have been checked for the lot number (4509255106) and found to be according to the specification, valid at the time of production. No similar incidents have been filed with products from this batch. No product available and therefore it is hardly possible to determine an exact conclusion and root cause. It is assumed that the cause of the failure is not product related. There us the possibility that the root cause of the problem is most probably usage related. Unfortunately due to a lack of data and without the product we cannot determine the exact cause. According to the quality standard and dhr files a material defect and production error can be excluded. There is the possibility for a usage error due to an improper handling. The breakage could have been caused due to a mechanical overload situation.
Patient Sequence No: 1, Text Type: N, H10
[133752023]
It was reported by the healthcare professional "during the clamping maneuvers of a small drainage, it breaks in the upper part with detachment of the grippers and of the metal part". Additional information has been requested however, not yet received. If additional information is received a follow up report will be submitted. No harm to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00033 |
| MDR Report Key | 8267099 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-12-21 |
| Date Facility Aware | 2019-01-14 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2018-03-19 |
| Date Added to Maude | 2019-01-22 |
| 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 | MRS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 3 |
| Brand Name | SUSI MAYO-HEGAR NEEDLEHOLDER 150MM |
| Generic Name | NEEDLE HOLDER, SINGLE |
| Product Code | HXK |
| Date Received | 2019-01-22 |
| Model Number | BM235SU |
| Catalog Number | BM235SU |
| Lot Number | 4509255106 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| 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 | 2019-01-22 |