MULTI CLIP APPLIER LIGACLIP MEDIUM CLIPS
Received Dec 17, 2021 · Event occurred Nov 5, 2021
Report 2134070-2021-00034 · MDR key 13025831
Device
Generic name
Clip, Implantable, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
ETHMCM20Catalog number
ETHMCM20
Lot number
2153756
Product problems
- Failure to Fire
- Mechanical Jam
- Failure to Fire
- Mechanical Jam
Patient
56 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS ORIGINALLY REPORTED THAT A 56-YEAR-OLD, MALE, PATIENT UNDERWENT A LAPAROSCOPIC OPEN CHOLECYSTECTOMY PROCEDURE WITH FOUR REPROCESSED CLIP APPLIERS LIGACLIP AND DURING THE PROCEDURE, THE FOUR CLIP APPLIERS FAILED TO FIRE. ADDITIONAL INFORMATION WAS RECEIVED 17-DEC-2021 THAT THE ISSUE WAS THE CLIPS DID NOT ADVANCE/FEED AND NOT A FAILURE TO FIRE. IN ADDITION, THERE WAS NO PROBLEM WITH HOW THE CLIPS FORMED. WITH THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT HAS BEEN REASSESSED AS A NOT MDR REPORTABLE EVENT. MANUFACTURER'S REF. NO: (B)(4)
Description of Event or Problem
IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A LAPAROSCOPIC OPEN CHOLECYSTECTOMY PROCEDURE WITH FOUR REPROCESSED CLIP APPLIERS LIGACLIP AND, DURING THE PROCEDURE, THE FOUR CLIP APPLIERS FAILED TO FIRE. A FIFTH CLIP WAS USED AND WORKED AS EXPECTED. THERE WAS NO PATIENT CONSEQUENCE.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN REPORTED AS NOT AVAILABLE FOR RETURN. THE FOLLOWING REPORTS ARE RELATED TO THE SAME EVENT: 2134070-2021-00033, 2134070-2021-00035 AND 2134070-2021-00036. MANUFACTURER'S REF. NO: (B)(4).