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

Model Number 27040GP1

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Material Fragmentation (1261)

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

Event Date 07/08/2023

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It reported that a new loop was used for the surgical procedure and in the middle of the endoscopic bladder surgery, a part of the loop was broken; this part of the loop is seen by the camera in the video tower.

Manufacturer Narrative

Additional information is provided in section.The device is not available to be returned to manufacturer.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

A new handle was used for surgical procedures and in between endoscopic bladder surgery.Evidence of rupture of a part of the loop; this part of the handle is seen by the camera in the video tower.There were no adverse consequences to patient user or third due to this incident, no surgical delay, and no additional intervention was necessary.

Manufacturer Narrative

The complaint product was not available for investigation.The complaint sample has been requested at least 3 times.A investigation of the complaint device itself was not possible, but pictures were provided by customer.Based on these pictures, the customer's description and the similar complaints, it can be assumed that this damage was caused by overloading the item.This damage may have been caused by too much force or too long a peak voltage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Type of Device: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17326756
• MDR Text Key: 319051935
• Report Number: 9610617-2023-00160
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: XN37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• 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