HARMONIC SCALPELS/SHEARS
Received Sep 23, 2021 · Event occurred Sep 2, 2021
Report 2134070-2021-00021 · MDR key 12523518
Device
Generic name
Electrosurg, Cut/coag Access, Laparoscopic & Endoscopic
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO:(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND DURING COLPOTOMY CREATION WHEN THE BLADE CAME IN CONTACT WITH THE UTERINE MANIPULATOR THE ACTIVE BLADE BROKE. BROKEN PIECE WAS RECOVERED WITHOUT ADDITIONAL ASSISTANCE. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK. ANOTHER REPROCESSED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THIS EVENT HAS BEEN ASSESSED AS NOT MDR REPORTABLE.