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 2018-11-21 for NEEDLE HOLDER S52174 manufactured by Aesculap Ag.
[128112159]
(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
[128112160]
It was reported that it was very difficult to open and close the arms of the needleholder during surgery. A patient underwent a cardiac procedure and suturing was being performed on the mitral ring. Because of the malfunction, the needle could not be readily removed/passed through the tissue. There was a small tissue injury on the mitral ring with minimal consequence to the patient. The patient outcome was described as "well".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00518 |
| MDR Report Key | 8096889 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-21 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-09-12 |
| Date Facility Aware | 2018-11-27 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-11-21 |
| 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 | NEEDLE HOLDER |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | HRQ |
| Date Received | 2018-11-21 |
| Model Number | S52174 |
| Catalog Number | S52174 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-11-21 |