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

Model Number	26183MC-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).Evaluation findings: the metal part at the top of the loop has parted.The ends of the parted wires are burnt.The plastic insulation is melted where the wire is exposed.There is black residue on the plastic.Signs of customer use: yes.Evidence of use: broken loop, melted insulation, black residue.Possible manufacturer's defect: yes.The defect location is the general area of the instrument and it is defined as broken by mechanical damage generally a user error.
Event or Problem Description
It was reported that the unit broke during case.While separating the uterus from the cervix, the loop broke.There was no patient impact, and the doctor was able to complete the case with another loop from the same box.Lot is 37ja97975, which happened to be part of the last rma 200041212 that was replacing other loops.Customer will be checking to see if they have any more of these lot code loops on the shelf.

• 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 Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17385574
• Report Number: 9610617-2023-00174
• Device Sequence Number: 12337891
• Product Code: KNF
• UDI-Device Identifier: 04048551393086
• UDI-Public: 4048551393086
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 26183MC-S
• Device Catalogue Number: 26183MC-S
• Device Lot Number: 37JA97975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown