HARMONIC SCALPELS/SHEARS
Received Dec 8, 2021 · Event occurred Oct 29, 2021
Report 2134070-2021-00030 · MDR key 12962544
Device
Generic name
Electrosurg, Cut/coag Accessories, Laparoscopic & Endoscopic, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
HAR36RCatalog number
HAR36R
Lot number
2161136
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 NOT YET BEEN RETURNED FOR ANALYSIS. MANUFACTURER'S REF. NO: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TIP OF DEVICE WAS BROKEN. IT IS UNKNOWN IF IT COMPLETELY DETACHED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Additional Manufacturer Narrative
A NON-REPROCESSED ORIGINAL EQUIPMENT MANUFACTURER (OEM) DEVICE WAS RECEIVED BY STERILMED ON 16-DEC-2021 FOR ANALYSIS OF THIS COMPLAINT. FOLLOW UP WAS PERFORMED TO CONFIRM IF THIS WAS THE CORRECT DEVICE OF THIS COMPLAINT. CONFIRMATION WAS RECEIVED ON (B)(6) 2021 THAT THE DEVICE RETURNED IS THE CORRECT DEVICE FOR THE COMPLAINT AND THE INCORRECT REPROCESSED PRODUCT CODE WAS PREVIOUSLY PROVIDED. THEREFORE, STERILMED IS NOT THE MANUFACTURER OF THIS DEVICE, AND THIS COMPLAINT IS NOT FOR STERILMED. THE OEM ETHICON INC. HAS BEEN NOTIFIED OF THIS INFORMATION. MANUFACTURER'S REF. NO: (B)(4).