MAUDE Adverse Event Report: STRYKER CORPORATION MONOPOLAR SCISSORS; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 0250181164

Device Problem Defective Device (2588)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Thermal injury to patient abdominal wall due to instrument malfunction/defect.The laparoscopic monopolar scissors that are in the davinci multi-port set cause several thermal burns 1-2 inches back from the tips when being used on energy.

• Brand Name: MONOPOLAR SCISSORS
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 15814044
• MDR Text Key: 303805838
• Report Number: 15814044
• 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: 11/09/2022,11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0250181164
• Device Catalogue Number: 0250-181-164
• Device Lot Number: 2040218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Date Report to Manufacturer: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other