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

Model Number 27040GP1-S

Device Problem Defective Component (2292)

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

Event Date 07/14/2021

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.Evaluation findings: loop misalignment, melted plastic insulation, residue and burnt prong.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that parts of the device broke off in the patient's body during the procedure.The surgeon was able to retrieve all pieces and no patient harm is reported.

• 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: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18070526
• MDR Text Key: 327375769
• Report Number: 9610617-2023-00355
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/04/2023
• 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