HARMONIC SCALPELS/SHEARS
Received Sep 17, 2021 · Event occurred Apr 2, 2021
Report 2134070-2021-00019 · MDR key 12489130
Device
Generic name
Electrosurg, Cutting/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
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR RETURN, 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 A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TISSUE PAD BROKE OFF INSIDE OF THE PATIENT. THE PAD WAS FOUND AND REMOVED FROM THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE.