LIGACLIP
Received Jul 7, 2026 · Event occurred Jun 19, 2026
Report 3005075853-2026-05323 · MDR key 25734316
Device
Generic name
Clip, Implantable
Manufacturer
Ethicon Endo-surgery, Llc.Catalog number
ER320
Lot number
951D97
Product problems
- Failure to Form Staple
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPS NOT FORMING, TRIED MULTIPLE TIMES MID PROCEDURE. OPENED A NEW ONE AND IT WORKED FINE. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WAS THERE A PATIENT IMPACT? (IF YES PLEASE EXPLAIN) NO.
Additional Manufacturer Narrative
(B)(4). DATE SENT: 7/7/2026. D4 BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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.