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

Model Number 27040EB

Device Problem Sparking (2595)

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

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The device is not available for investigation.Customer has taken a picture showing the neutral eletrode part is molten down and the working electrode is also broken and partial molten.Form the kind of damage, we assume that there has been a short cut between the electrodes.Most likely, the working electrode got broken and touched or came too close to the neutral electrode resulting in a short cut and high current flow which heated up the metal above the melting point.Why the working electrode broke can't be determined - in similar cases, there has been excessive force applied to the neutral electrode or it has been operated too long and got worn out.Complaint statistics show no other complaints on this batch.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that during a endometrial ablation for menorhagia, it came to an incident.Procedure started without problems, anterior wall was almost fully resected.Sudden "explosion" with light flashes like fire inside the cavity of the uterus.Procedure was stopped immediately.Video recording was taken to show the burned lesion inside the patient.No perforation was seen so no further danger for bowel damage or damage to other organs.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Type of Device: WORKING ELEMENT, 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: 16974014
• MDR Text Key: 315783415
• Report Number: 9610617-2023-00637
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: OS06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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
• Patient Outcome(s): Other