MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-07-07 for TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G 450-510 manufactured by .
[21254977]
The user facility reports that the tonsil snare failed to cut through tissue and release, necessitating the surgeon to remove additional tissue to free the snare and tonsil tissue. The snare push rod that is attached to the movable handle, jumped out of the channel and jammed, preventing the snare contraction around tonsil. The surgery technician had to remove the thumbscrew to reset the snare. It appears that the distal channel is bent. The physician was concerned about where the snare was positioned, too close to carotid artery.
Patient Sequence No: 1, Text Type: D, B5
[21433723]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information. Integra lifesciences corporation is filing on behalf of the initial distributor j. Jammer surgical instruments.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2008-00023 |
| MDR Report Key | 1073942 |
| Report Source | 05,06,07 |
| Date Received | 2008-07-07 |
| Date of Report | 2008-07-07 |
| Date of Event | 2008-06-17 |
| Date Facility Aware | 2008-06-17 |
| Report Date | 2008-07-07 |
| Date Mfgr Received | 2008-06-17 |
| Date Added to Maude | 2010-04-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Manufacturer G1 | IIG INSTRUMENTE GMBH |
| Manufacturer Street | DORFSTRASSE 2 |
| Manufacturer City | DURCHHAUSEN 78591 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78591 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G |
| Generic Name | JARIT THROAT/LARYNGEAL |
| Product Code | KBZ |
| Date Received | 2008-07-07 |
| Returned To Mfg | 2008-06-20 |
| Catalog Number | 450-510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-07 |