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

Device Problem Defective Device (2588)

Patient Problem Laceration(s) (1946)

Event Date 06/19/2019

Event Type  Injury  

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 78532 ; GM 78532
• MDR Report Key: 8785856
• MDR Text Key: 151197573
• Report Number: MW5088066
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551393574
• UDI-Public: (01)04048551393574
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26183MD-S
• Device Catalogue Number: 26183MD-S
• Device Lot Number: 37CH2713
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 83