LIGACLIP
Received Jul 7, 2026 · Event occurred Jun 16, 2026
Report 3005075853-2026-05362 · MDR key 25737587
Device
Generic name
Clip, Implantable
Manufacturer
Ethicon Endo-surgery, Llc.Catalog number
ER320
Lot number
895D00
Product problems
- Failure to Form Staple
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). DATE SENT: 7/7/2026. D4: BATCH # 895D00. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER OF 895D00 / 48ER320, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 THE UNK SURGERY. AFTER CLAMPED THE CLIPS FOUND CLIP FELL OFF. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.