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 2018-12-20 for DUROGRIP NEEDLE HOLDER STR.D:5/310MM PL407R manufactured by Aesculap Ag.
[131126822]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[131126823]
It was reported that a mechanism of the needle holder broke during surgery. During an unknown procedure, when the suture was placed, an internal mechanism of the durogrip needle holder broke. This issue created a surgical delay of 30 minutes. Additional details have been requested but not yet provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00597 |
| MDR Report Key | 8187224 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-01 |
| Date Facility Aware | 2018-12-12 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Brand Name | DUROGRIP NEEDLE HOLDER STR.D:5/310MM |
| Generic Name | INSTRUMENTS |
| Product Code | HXK |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-12-10 |
| Model Number | PL407R |
| Catalog Number | PL407R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-12-20 |