MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2006-06-22 for 5/12MM UNIVERSAL CONVERTER 1700 manufactured by Conmed Corp..
[18967972]
It was reported by hospital line, a greek distributor, that during a surgical procedure, the seal inside of a converter was dislodged and it dropped in to the patient. The seal was retrieved. There was no patient injury, the surgical procedure was not altere and the time was not extended.
Patient Sequence No: 1, Text Type: D, B5
[19034908]
The actual device is being retained by the hospital in greece. It is not available for evaluation. We are unable to determine what may have caused the seal to become dislodged. No investigation can be done. The product complaint database has been searched. This is the onkly complaint of any type for this product this year. There have been no other complaints for this lot code at any time. We consider this complaint closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2006-00044 |
| MDR Report Key | 730552 |
| Report Source | 01,08 |
| Date Received | 2006-06-22 |
| Date of Report | 2006-06-22 |
| Date of Event | 2006-05-17 |
| Date Mfgr Received | 2006-05-26 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-07-03 |
| 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 | 0 |
| Manufacturer Contact | NANCY CRISINO, SUPERVISOR |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243078 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5/12MM UNIVERSAL CONVERTER |
| Generic Name | TROCER SYSTEM SIZE CONVERTER |
| Product Code | FBM |
| Date Received | 2006-06-22 |
| Model Number | NA |
| Catalog Number | 1700 |
| Lot Number | 0511021 |
| ID Number | NA |
| Device Expiration Date | 2010-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 718840 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | * UTICA NY * US |
| Baseline Brand Name | 5/12MM UNIVERSAL CONVERTER |
| Baseline Generic Name | TROCER SYSTEM SIZE CONVERTER |
| Baseline Model No | NA |
| Baseline Catalog No | 1700 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-22 |