LIGAMAX
Received Jul 6, 2026 · Event occurred Jan 1, 2026
Report 3005075853-2026-05258 · MDR key 25716784
Device
Generic name
Clip, Implantable
Manufacturer
Ethicon Endo-surgery, Llc.Catalog number
EL5ML
Lot number
A70119
Product problems
- Failure to Form Staple
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). DATE SENT: 7/6/2026 B3: EXACT EVENT DATE UNK, ENTERED 1/1/2026 AS ONLY THE YEAR WAS PROVIDED. D4: BATCH # UNK. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WEREN'T FORMING COMPLETELY AND THIS HAPPENED IN MULTIPLE CASES. NO PATIENT CONSEQUENCES.