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 2017-04-03 for PURSE STRING CLAMP EA323R manufactured by Aesculap Ag.
[71582995]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[71582996]
Country of complaint: (b)(6). It was reported that the forceps (purse string clamp was used for surgery. The suture did not hold, the forceps did not function properly. New operation was necessary due to lesion. All med watch submissions related to this report are: 9610612-2017-00177, 9610612-2017-00185. Incident was reported by the same initial reporter by mdrs: 9610612-2017-00083 and 9610612-2017-00093. Its unknown if these were used on the same patient with information reported.
Patient Sequence No: 1, Text Type: D, B5
[74933146]
Investigation: the investigation was carried out by ats. The movement of the clamp with the labeling (b)(4) is a little bit too smooth. The correct function is still given, the instrument is working. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers. The device history file has been checked and found to be according to our specification 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 user related. Rational: according to the investigation of ats, the instruments are working. Thus is can exclude a material or manufacturing caused error. Corrective action: according to sop (b)(4) a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610612-2017-00177 |
| MDR Report Key | 6455137 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-03 |
| Date of Report | 2017-05-08 |
| Date Facility Aware | 2017-03-20 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2017-04-03 |
| 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 | PURSE STRING CLAMP |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FFN |
| Date Received | 2017-04-03 |
| Returned To Mfg | 2017-03-20 |
| Model Number | EA323R |
| Catalog Number | EA323R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 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 | 2017-04-03 |