MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.; BIPOLAR CUTTING LOOP

Model Number 27040GP1

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Device was not returned for investigation.No available result yet.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): on (b)(6) 2021, during a surgical intervention, the bipolar resection loop again separated at the level of the yellow fixation systems.The material is lost between the bladder and the urethra with risks of perforation.

Manufacturer Narrative

Upon investigation, it could be confirmed that the loop was bent.Also, at the breaking point of the loop, it can be seen that the wire has melted; this could potentially have been caused by a short circuit when the electrode came too close to the neutral electrode during use.The root cause is most likely due to mechanical overload, i.E.User error.No indication for material or manufacture defect found during investigation.Ifu already included a warning that a mechanical overload can provoke a potential risk for the patient.

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11863538
• MDR Text Key: 251975410
• Report Number: 9610617-2021-00045
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (y/n): N
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: SP38
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability