HARMONIC SCALPELS/SHEARS
Received Mar 2, 2022 · Event occurred Feb 1, 2021
Report 2134070-2022-00006 · MDR key 13655507
Device
Generic name
Electrosurgical, Cut/coag Accessories, Laparoscopic & Endoscopic, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
HAR36RCatalog number
HAR36R
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE USING A REPROCESSED HARMONIC SCALPELS/SHEARS THE DEVICE BLADE BROKE OFF. FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.