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

Model Number	26183MC-S
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); 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.
Additional Manufacturer Narrative
The device was returned to our us facility on oct-29-2024, and will later 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).
Additional Manufacturer Narrative
Per evaluation findings from the manufacturing site: during the technical investigation of the returned product, the following was found: the cutting wire shows signs of melting/burning at both break points, which can be attributed to the effect of excessively high temperatures.This can cause the wire to break.Some of the insulation is missing.There are discolorations/deposits on the cutting wire, which indicates that some cuts have already been made.The most probable cause is user error.According to ifu: 26183m, the article may only be used briefly with a peak voltage of max.4.5 kvp.If this usage time is exceeded, this error pattern may occur.Premature loading without tension can also cause the sling to break.This event is filed under internal complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 20458045
• Report Number: 9610617-2024-00384
• Device Sequence Number: 8701687
• Product Code: KNF
• UDI-Device Identifier: 04048551393086
• UDI-Public: 04048551393086
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K944793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 12/12/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/05/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female