MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BRUCKER/MESSROGHLI SUPRALOOP; SPARE SUPRA LOOP STERILE PACKAGE OF 6

Model Number 26183MC-S

Device Problems Break (1069); Material Separation (1562)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

During a laparoscopic supra cervical hysterectomy with bso, the loop snapped rather than cutting when cautery pedal was deployed.The surgeon completed the case with another small loop, with no impact to the patient.

Manufacturer Narrative

The product has been returned, however, the evaluation has not been completed.

Manufacturer Narrative

Per evaluation from kst/mfr."based on the inspection of the instrument, the most probable root cause is that the customer operated the device incorrectly.Probably too much force was applied to the loop without activating the hf current, moreover, the current was too high, which led to overheating/damage to the instrument which has black discolorations at the breakage points.".

• Brand Name: BRUCKER/MESSROGHLI SUPRALOOP
• Type of Device: SPARE SUPRA LOOP STERILE PACKAGE OF 6
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14643315
• MDR Text Key: 293836491
• Report Number: 9610617-2022-00080
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: UO07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female