MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-14 for PURSE STRING CLAMP EA323R manufactured by Aesculap Ag.
[70302085]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[70302086]
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: 9610612-2017-00083; 9610612-2017-00093.
Patient Sequence No: 1, Text Type: D, B5
[74515652]
Correction made to: product code. Product code ffn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610612-2017-00083 |
| MDR Report Key | 6403573 |
| Date Received | 2017-03-14 |
| Date of Report | 2017-04-27 |
| Date Facility Aware | 2017-02-15 |
| Date Mfgr Received | 2017-02-13 |
| Date Added to Maude | 2017-03-14 |
| 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 | PURSE STRING CLAMP |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FNN |
| Date Received | 2017-03-14 |
| Returned To Mfg | 2017-02-20 |
| Model Number | EA323R |
| Catalog Number | EA323R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-03-14 |