UW RUB. DAM CLAMP FCPS
Received Nov 3, 2020 · Event occurred Oct 7, 2020
Report 2523190-2020-00126 · MDR key 10782684
Device
Product problems
- Break
- Break
Patient
Not reported
- Pain
- Injury
- Pain
- Injury
Narrative
Additional Manufacturer Narrative
ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE RUBBER DAM CLAMP FORCEPS BROKE DURING A DENTAL PROCEDURE RESULTING IN A CHIPPED LOWER LATERAL TOOTH. THE PATIENT WAS COMPLAINING OF PAIN AND DISCOMFORT AND THE TOOTH WAS REPAIRED WITH FILLING. THE BROKEN PIECE WAS RETRIEVED, AND THE PATIENT IS DOING WELL.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RUBBER DAM CLAMPS WERE NOT RETURNED FOR EVALUATION (THEY PURCHASED ADDITIONAL RUBBER DAM CLAMPS AS A REPLACEMENT); HOWEVER, IMAGE WAS PROVIDED AND EVALUATED: PER THE PROVIDED IMAGE, THESE 76-15 FORCEPS ARE IN USED CONDITION WITH THE TIPS BROKEN OFF DUE TO ROUGH HANDLING OR EXCESSIVE FORCE. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ADDITIONAL INFORMATION RECEIVED - THERE WAS A DELAY FOR 20 MINUTES BECAUSE TOOTH NUMBER 24 INCISAL LINGUAL EDGED WAS CHIPPED WHEN THE CLAMPS BROKE.