MAUDE Adverse Event Report: STRYKER ENDOSCOPY MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 250-040-112

Device Problem Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 05/18/2017

Event Type  Injury  

Event Description

Patient underwent a laparoscopic cholecystectomy at an outside facility.At the end of the procedure, the surgeon discovered a thermal injury to the anterior distal stomach caused by a defect in the insulation of the cautery shaft.A modified graham patch was performed.

• Brand Name: MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 6661424
• MDR Text Key: 78195992
• Report Number: 6661424
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 250-040-112
• Device Catalogue Number: 250-040-112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention