MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BRUCKER/MESSROGHLI SUPRALOOP SPARE LOOP

Model Number	26183MC-S
Medical Device Problem Codes	Break (1069); Excessive Heating (4030)
Health Effect - Clinical Codes	Bowel Burn (1756); Burn(s) (1757)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during a surgery on (b)(6) 2024, the supraloop broke causing injury to the ovary and bowel during cautery around the uterus.The supraloop was removed and a new supraloop was used without further issues.Approximately one hour was added to the procedure due to this issue.

• Brand Name: BRUCKER/MESSROGHLI SUPRALOOP SPARE LOOP
• Common Device Name: BRUCKER/MESSROGHLI SUPRALOOP SPARE LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 20457840
• Report Number: 2020550-2024-00384
• Device Sequence Number: 8856127
• Product Code: KNF
• UDI-Device Identifier: 04048551393086
• UDI-Public: 04048551393086
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2024
• Report Date (Section F): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26183MC-S
• Device Catalogue Number: 26183MC-S
• Device Lot Number: 37BD4693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• 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: 41 YR
• Patient Sex: Female