MAUDE Adverse Event Report: STRYKER ENDOSCOPY INSERT, COBRA GRASPER; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 0250080317

Device Problem Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 07/25/2019

Event Type  malfunction  

Event Description

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.

• Brand Name: INSERT, COBRA GRASPER
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 9995479
• MDR Text Key: 188834025
• Report Number: 9995479
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0250080317
• Device Catalogue Number: 0250-080-317
• Device Lot Number: 5527339
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8030 DA