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 03/22/2022

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.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 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
• 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: 17385574
• MDR Text Key: 319950318
• Report Number: 9610617-2023-00174
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• 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: 37JA97975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1