inforMED
MalfunctionOCZ

INSERT, COBRA GRASPER

Received Apr 24, 2020 · Event occurred Jul 25, 2019

Report 9995479 · MDR key 9995479

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered

Manufacturer

Stryker Endoscopy

Model number

0250080317

Catalog number

0250-080-317

Lot number

5527339

Product problems

  • Difficult to Open or Close

Patient

8030 DA

  • Tissue Damage
  • Tissue Damage

Narrative

Description of Event or Problem

PATIENT HAVING DIAGNOSTIC LAPAROSCOPY AND FULGURATION OF ENDOMETRIOSIS. DURING PROCEDURE, LAPAROSCOPIC GRASPER WAS USED TO HOLD TISSUE. GRASPER BECAME LOCKED ONTO PERITONEAL TISSUE, NEAR POSTERIOR CUL-DE-SAC, AND SURGICAL TEAM WAS UNABLE TO OPEN OR RELEASE INSTRUMENT DESPITE MULTIPLE ATTEMPTS BY DIFFERENT TEAM MEMBERS. TISSUE AROUND GRASPER WAS EXCISED AND CAUTERIZED BY SURGEON AND INSTRUMENT EXTRACTED. PER DOCTOR'S OPERATIVE REPORT, THE PROCEDURE PERFORMED WAS "DIAGNOSTIC LAPAROSCOPY; WITH FULGURATION OF ENDOMETRIOSIS." THE PROCEDURE DESCRIPTION INCLUDES THAT THERE WAS "DIFFICULTY WITH THE GRASPER, WE COULD NOT OPEN THIS GRASPER" THEREFORE "PORT SCISSORS WERE USED TO EXCISE THE PORTION OF PERITONEUM." THE GRASPER WAS THEN REMOVED FROM THE ABDOMEN WITH THE SMALL PIECE OF TISSUE. MILD BLEEDING WAS CONTROLLED WITH CAUTERY. THE PROCEDURE CONTINUED WITH NO FURTHER INCIDENT.