SUTURE PASSER
Received Feb 11, 2026
Report 9610617-2026-00273 · MDR key 24317432
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OUR US FACILITY ON MARCH 19, 2026. IT WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER WAS USING A SUTURE PASSER INSTRUMENT DURING A LAPAROSCOPIC APPENDECTOMY AND THE TIP BROKE INSIDE THE TISSUE OF THE ABDOMINAL WALL. THE TIP WAS REMOVED FROM THE PATIENT USING C-ARM GUIDANCE.