STOCKES RUBBER DAM CLAMP FORCEPS
Received Dec 15, 2020 · Event occurred Oct 7, 2020
Report 8010168-2020-00002 · MDR key 11010988
Device
Generic name
Rubber Dam Clamp Forceps
Manufacturer
Geomed Medizin-technik Gmbh & Co. KgCatalog number
76-15 / DH 381-17-50
Product problems
- Fracture
- Fracture
Patient
Not reported
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER WAS PROVIDED FOR DHR REVIEW. REVIEW OF COMPLAINT HISTORY FOR 2018-2020 REVEALED THAT NO PREVIOUS COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEVICE. PER THE PROVIDED IMAGE, THE FORCEPS ARE IN USED CONDITION WITH THE JAW TIPS BROKEN OFF DUE TO ROUGH HANDLING OR EXCESSIVE FORCE.
Description of Event or Problem
THE RUBBER DAM CLAMP FORCEPS BROKE DURING A DENTAL PROCEDURE RESULTING IN A CHIPPED TOOTH NUMBER 24. THE PATIENT COMPLAINED OF PAIN AND DISCOMFORT AND THE TOOTH WAS REPAIRED WITH FILLING, CAUSING A 20-MINUTE DELAY IN TREATMENT. THE BROKEN PIECE OF THE FORCEPS WAS RETRIEVED. THE PATIENT IS DOING WELL.