FDA Adverse Event
Summary report: N
NEIVERT TONSIL SNARE
MDR report key: 88135
·
Received January 30, 1995
Report
- Report Number
- 88135
- Date Received
- January 30, 1995
- Manufacturer
- WECK (PILLING WECK CORP)
- Product Code
- KBZ
- Report Source
- User Facility report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
ON 11/15/94, A 4 YEAR OLD WAS ADMITTED FOR A TONSILLECTOMY. DURING THE SURGICAL PROCEDURE, BLUNT DISSECTION PARTIALLY FREED THE TONSIL. WHILE REMOVING IT WITH A SNARE WIRE, THE TIP OF THE SNARE UNIT BROKE. THIS SMALL METALLIC END OF THE SNARE WAS NOT LOCATED VISUALLY BY DIRECT LARYNGOSCOPY OR BY X-RAY OF THE CHEST WHICH INCLUDES THE UPPER HALF OF THE ABDOMEN. HYPOTHESIS IS THAT THE MISSING TIP OF THE SNARE MAY HAVE BEEN SUCTIONED OUT DURING THE PROCEDURE, OR IF RETAINED, WILL PASS THROUGH THE GASTROINTESTINAL TRACT. MFR'S REP WAS NOTIFIED. 1/5/95 DELAY IN NOTIFICATION WAS DUE TO HOSP'S DIFFICULTY IN IDENTIFYING THE INSTRUMENT'S MFR. 1/10/95, MFR'S REP IDENTIFIED PRODUCT AND THE TONSIL SNARE WAS GIVEN TO HIM AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEIVERT TONSIL SNARE | NEIVERT TONSIL SNARE | KBZ | WECK (PILLING WECK CORP) | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |