MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG 200MM X 150MM BRUCKER / MESSROGHLI EXTRA LARGE SUPER LOOP SPARE LOOP ; ELECTROSURGICAL, CUTTING, COAGULATION

Model Number	26183MD-S
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Sigmoid colon nicked during surgery.Surgeon stated the "nick" was a result of a defective product (super loop).

• Brand Name: 200MM X 150MM BRUCKER / MESSROGHLI EXTRA LARGE SUPER LOOP SPARE LOOP
• Common Device Name: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 78532 ; GM 78532
• MDR Report Key: 8785856
• Report Number: MW5088066
• Device Sequence Number: 3205942
• Product Code: GEI
• UDI-Device Identifier: 04048551393574
• UDI-Public: (01)04048551393574
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: 26183MD-S
• Device Catalogue Number: 26183MD-S
• Device Lot Number: 37CH2713
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 83