MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for RETAINING ARM BV829R manufactured by Aesculap Ag.
[111849654]
(b)(4). Manufacturing site evaluation: the clamping lever is broken off. Due to the damage, the return spring and the sleeve fell off the device. The investigation was performed using a digital microscope. The analysis of the fracture pattern illustrated a forced fracture due to overload. No pores, inclusions or foreign bodies could be found on the point of rupture. The hardness test confirmed the pre-set values. The corrosion on the fracture surface is most likely caused by reprocessing. No deviations can be found at the sleeve and the compression spring. Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[111849655]
Country of complaint: (b)(6). It is reported that the handle broke after first use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00264 |
| MDR Report Key | 7611564 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-05-25 |
| Date Facility Aware | 2018-06-12 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2018-06-18 |
| 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 | 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 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 | RETAINING ARM |
| Generic Name | SPREADERS, SELF-RETAINING RETRACTOR |
| Product Code | FFO |
| Date Received | 2018-06-18 |
| Returned To Mfg | 2018-06-13 |
| Model Number | BV829R |
| Catalog Number | BV829R |
| Lot Number | 52403941 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 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 | 1. Other | 2018-06-18 |