MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-04-30 for FORCEPS MCL19BIS RIGHT BOUCHAYER HEART manufactured by Xomed Microfrance Mfg.
[20265761]
It was reported the tip of the forceps is? Broken off?. It was confirmed with the facility that the tip was bent, not broken. There was no patient impact. Product analysis found that the mobile jaw is broken and a fragment is missing.
Patient Sequence No: 1, Text Type: D, B5
[20498977]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00037 |
| MDR Report Key | 3782168 |
| Report Source | 06,07 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-04-08 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2014-04-08 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2014-06-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS MCL19BIS RIGHT BOUCHAYER HEART |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2014-04-30 |
| Returned To Mfg | 2014-04-07 |
| Model Number | MCL19BIS |
| Catalog Number | MCL19BIS |
| Lot Number | 100403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-30 |