inforMED
MalfunctionPTS

OTSC TWIN GRASPER

Received Sep 2, 2025 · Event occurred May 31, 2025

Report 22930459 · MDR key 22930459

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered, Exempt

Model number

220 CM

Catalog number

200.45

Lot number

221423

Product problems

  • Entrapment of Device
  • Retraction Problem

Patient

86 YR · Female

  • Hemorrhage/Blood Loss/Bleeding
  • Ulcer
  • Fibrosis
  • Hemorrhage/Blood Loss/Bleeding
  • Ulcer
  • Fibrosis

Narrative

Description of Event or Problem

DUE TO BLEEDING REFRACTORY TO STANDARD CLIPPING, AN OVER-THE-SCOPE CLIP (OVESCO) WAS PLACED TO AVOID SURGICAL INTERVENTION. AFTER REMOVING THE INITIAL CLIPS, THE OVESCO CLIP WAS SUCCESSFULLY DEPLOYED OVER THE ULCER. THE TWIN GRASPER WAS USED TO APPROXIMATE AND DRAW TISSUE INTO THE CAP, WHICH INHERENTLY LIMITS VISUALIZATION AND CARRIES A KNOWN RISK OF INSTRUMENT ENTRAPMENT. IN THIS CASE, DENSE FIBROSIS AROUND THE ULCER PREVENTED THE TWIN GRASPER FROM COMPLETELY RETRACTING, RESULTING IN ITS ACCIDENTAL CAPTURE DURING CLIP DEPLOYMENT¿A RECOGNIZED COMPLICATION. THE PROVIDER NOTED PRIOR EXPERIENCE WITH THIS SCENARIO DURING TRAINING AT ANOTHER FACILITY. THIS IS AMONG THE DOCUMENTED INDICATIONS FOR THE REMOVE SYSTEM, DESIGNED TO REMOVE OVESCO CLIPS. RELEVANT INDICATIONS INCLUDE: MISPLACED CLIP, ACCIDENTAL CLIPPING OF AN INSTRUMENT, LOCAL COMPLICATIONS (E.G., OBSTRUCTION), NEED FOR RE-BIOPSY OR RESECTION. THIS CASE ALIGNS PRECISELY WITH THE SECOND INDICATION¿ACCIDENTAL INSTRUMENT ENTRAPMENT¿DESPITE ADHERENCE TO ALL RECOMMENDED PREVENTIVE MEASURES.