MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-22 for SAGE TONSIL SNARE 280MM & SNARE WIRES MA493R manufactured by Contract Manufacturer: Avalign German Specialty In.
[44369902]
During a tonsillectomy and adenoidectomy (t&a) procedure the tonsil snare seizes up when trying to cut the tonsil. It seems to hang up when pulling the wire loop back into the snare with the tonsil in the wire loop. The wire broke, and was missing about a millimeter of material. Intervention was needed to ensure piece was not in mouth or airway. Another snare froze up when trying to retract wire to cut tonsil. Surgery was delayed by several minutes. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00332 |
| MDR Report Key | 5600741 |
| Date Received | 2016-04-22 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-03-30 |
| Date Facility Aware | 2016-04-01 |
| Date Mfgr Received | 2016-04-01 |
| Date Added to Maude | 2016-04-22 |
| 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 | CONTRACT MANUFACTURER: AVALIGN GERMAN SPECIALTY IN |
| Manufacturer Street | AVALIGN GERMAN SPECIALTY INSTR 626 COOPER COURT |
| Manufacturer City | SCHAUMBURG IL 60173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAGE TONSIL SNARE 280MM & SNARE WIRES |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 2016-04-22 |
| Returned To Mfg | 2016-04-13 |
| Model Number | MA493R |
| Catalog Number | MA493R |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: AVALIGN GERMAN SPECIALTY IN |
| Manufacturer Address | AVALIGN GERMAN SPECIALTY INSTR 626 COOPER COURT SCHAUMBURG IL 60173 US 60173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-22 |