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 2016-01-14 for DUROGRIP NEEDLE HOLDER STR.D:5/310MM PL407R manufactured by Aesculap Ag.
[36051446]
(b)(4). Manufacturing site evaluation: on-going.
Patient Sequence No: 1, Text Type: N, H10
[36051447]
Country of complaint: (b)(6). The metal part which goes into the handle is not closing. There was no patient injury but a 30 minute delay in surgery as there were no others available to use. Additional report submitted at the same time, same facility, same event description. See 2916714-2016-00023.
Patient Sequence No: 1, Text Type: D, B5
[53385777]
The needle holders are in a used condition. The tips of the locking pin are broken off. The fragments are not available. The instruments were analyzed by microscope. No pores, inclusions or foreign bodies could be found. The device quality and manufacturing history records are not possible. Based on the information available as well as a result of the investigation, root cause of the failure is most probably a material error. The current failure rate is within the risk analysis and therefore acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2016-00022 |
| MDR Report Key | 5368537 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-01-14 |
| Date of Report | 2016-08-08 |
| Date Facility Aware | 2016-01-11 |
| Date Mfgr Received | 2016-06-23 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2016-01-14 |
| 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 |
| 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 | DUROGRIP NEEDLE HOLDER STR.D:5/310MM |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2016-01-14 |
| Returned To Mfg | 2016-01-14 |
| Model Number | PL407R |
| Catalog Number | PL407R |
| Device Availability | R |
| Device Age | 4 YR |
| 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 | 2016-01-14 |