MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR

Model Number 011160-01

Device Problem Flare or Flash (2942)

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

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.Upon evaluation the electrode was found to be bent, burned and melted.Both, the active and passive electrode are broken.The appearance of the breakage area of the active electrode indicates overloading.Due to a flashover from the passive electrode to the hopkins telescope - 27005ba and the inner sheath - 27050ca.Both devices got damaged and are showing signs of a flashover.The returned resectoscope sheath, 26 fr.- 27050sc is showing a weld point which was also caused by the flashover.The root cause most likely is overloading of the electrode by exerting too much force which caused the breakage and the flashover.No indication for a material or manufacturing related issue.Warning for risk of injury and damage is contained in the related ifu.Warning of overloading by exerting too much force is contained in the related ifu.The event is filed under internal karl storz complaint id (b)(4).

Event Description

As reported: "burn of the product during operation" product: 011160-01- electrode, bipolar no further information available.

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ELECTRODE, BIPOLAR
• 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: 17052933
• MDR Text Key: 317642103
• Report Number: 9610617-2023-00843
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-01
• Device Catalogue Number: 011160-01
• Device Lot Number: VQ59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• 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
• Treatment: 27005BA - HOPKINS® TELESCOPE 30°, 4 MM, 30 CM; 27050CA - INNER SHEATH FOR 27050 SC; 27050SC - RESECTOSCOPE SHEATH, 26 FR.