inforMED
MalfunctionOCZ

RAPTOR GRASPING DEVICE

Received Jun 15, 2021 · Event occurred Mar 1, 2020

Report 11999040 · MDR key 11999040

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered

Manufacturer

Us Endoscopy

Model number

00711177

Catalog number

00711177

Product problems

  • Break

Patient

14965 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

DURING PATIENT SURGICAL PROCEDURE, GRASPING DEVICE USED TO RETRIEVE FOREIGN BODY. THE HEAD OF THIS DEVICE BROKE OFF INSIDE THE PATIENT'S DISTAL COLON WHILE ATTEMPTING TO REMOVE ORIGINAL FOREIGN BODY THAT WAS GRASPED BY THIS DEVICE. NOT CERTAIN IF THIS PIECE REMOVED ALONG WITH ORIGINAL FOREIGN BODY FROM THE SUBSEQUENT COLON RESECTION. X-RAY TECHNICIAN INFORMED PRIOR TO POST-OP X-RAY. METAL GRASPING DEVICE. HEAD OF DEVICE BROKE IN ATTEMPT TO RETRIEVE ORIGINAL FOREIGN BODY. RAPTOR GRASPING DEVICE. SPOKE WITH RN: STATES PIECE OF RAPTOR GRASPING DEVICE THAT BROKE OFF WAS LESS THAN 1 CM IN SIZE. THE SURGEON WAS AWARE THE PIECE HAD BROKEN OFF. I ALSO SPOKE WITH PHYSICIAN. HE SAID THE SIZE OF THE ORIGINAL FOREIGN BODY (FB) WAS SO LARGE THAT IT RUBBED THE SIDES OF THE COLON ON EXTRACTION AND ANYTHING BELOW THE FB WAS REMOVED DUE TO THIS ACTION ALONE. ALTHOUGH HE DID NOT VISUALIZE THE PIECE OF GRASPING DEVICE, HE FELT CONFIDENT THAT IT WAS REMOVED. HE VIEWED THE POST-OP X-RAY HIMSELF PRIOR TO LEAVING THE OR AND THERE WAS NO FB IDENTIFIED ON THE X-RAY.