MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG MONOPOLAR DISSECTING HOOK CAUTERY; COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 37470DL

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

While using laproscopic hook cautery, an area that was not intended to be cauterized was in fact cauterized.Exposed metal was noted in the instrument shaft.The site was observed and no further action was taken.

• Brand Name: MONOPOLAR DISSECTING HOOK CAUTERY
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 9896898
• MDR Text Key: 185521295
• Report Number: 9896898
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37470DL
• Device Catalogue Number: 37470DL
• 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: 03/12/2020
• Event Location: Other
• Date Report to Manufacturer: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20440 DA