MEDLINE
Received Jul 8, 2026 · Event occurred Jun 11, 2026
Report 1423395-2026-00367 · MDR key 25753913
Device
Generic name
Ro-diep Pack
Manufacturer
Medline Industries, LpCatalog number
DYNJ82393C
Lot number
25IBS421
Product problems
- Failure to Seal
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2026 A "MEDIUM CLIP APPLIER WAS USED TO APPLY A CLIP TO A VESSEL AND INSTEAD OF APPLYING A CLIP THE DEVICE CUT THE VESSEL." PER THE CUSTOMER, "HEMOSTASIS WAS ACHIEVED WITH A BULLDOG CLIP AND REPAIR." THE SURGEON REPORTED "THE PATIENT IS DOING WELL." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2026 A "MEDIUM CLIP APPLIER WAS USED TO APPLY A CLIP TO A VESSEL AND INSTEAD OF APPLYING A CLIP THE DEVICE CUT THE VESSEL." PER THE CUSTOMER, "HEMOSTASIS WAS ACHIEVED WITH A BULLDOG CLIP AND REPAIR." THE SURGEON REPORTED "THE PATIENT IS DOING WELL."