MalfunctionHAM
HANDPIECE BOX OF 10
Received Mar 22, 2019 · Event occurred Mar 14, 2019
Report 1216677-2019-00134 · MDR key 8445950
Device
Generic name
Handpiece Box Of 10
Manufacturer
Coopersurgical, Inc.Model number
6040Catalog number
6040
Lot number
024234
Product problems
- Failure to Cut
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
WE HAVE ATTEMPTED SEVERAL PROCEDURES AND LEEP DID NOT WORK WITH THIS HAND PIECE. THE LOOPS WERE NOT CUTTING, SEVERAL LOOPS WERE TRIED AND THE CUTTING WAS SLUGGISH THE PROCEDURE WAS COMPLETED WITH THE USE OF SCALPEL.