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

Model Number 26183MC-S

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

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.There is a kink in the loop.The ends of the parted wires are burnt.The plastic insulation is melted where at the kink.There is black residue on the plastic.Signs of customer use: yes.Evidence of use: broken loop, kinked loop, melted insulation, black residue.

Event 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 37ka9619.It broke right at the distal end of the loop.

• Brand Name: BRUCKER/MESSROGHLI SUPRALOOP SPARE LOOP
• Type of Device: 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: 17397536
• MDR Text Key: 320174014
• Report Number: 9610617-2023-00179
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551393086
• UDI-Public: 4048551393086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26183MC-S
• Device Catalogue Number: 26183MC-S
• Device Lot Number: 37KA9619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2022
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1