MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-13 for EVES TONSIL SNARE, W/O RATCHET MO1980 manufactured by Cardinal Health.
[388670]
Customer states that "when mo1980 was used, the rivet on the handle "popped up" and the wire disengaged & had to be retrieved from the pt". Additionally, account stated the pin is too short and sometimes separates when trying to cut tonsil. They further stated they retrieve of the wire from the pt's was neccessary and was done with forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000008-2005-00002 |
| MDR Report Key | 602260 |
| Report Source | 05 |
| Date Received | 2005-05-13 |
| Date of Report | 2005-05-13 |
| Date of Event | 2005-04-14 |
| Date Mfgr Received | 2005-04-15 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2005-05-16 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKOGAN RD BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVES TONSIL SNARE, W/O RATCHET |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 2005-05-13 |
| Returned To Mfg | 2005-04-20 |
| Model Number | MO1980 |
| Catalog Number | MO1980 |
| Lot Number | A05 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 592088 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | EVES TONSIL SNARE, W/O RATCHET |
| Baseline Generic Name | TONSIL SNARE |
| Baseline Model No | MO1980 |
| Baseline Catalog No | MO1980 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-13 |