MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number 011250-10

Device Problem Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the patient undergoing hysteroscopic myomectomy.A box of hysteroscopy equipment was opened, and a bipolar loop was used: the patient received an electric shock.The patient received several electric discharges.The patient has been monitored post-surgery: stable on the anesthetic plan.Due to the reported electric shock as well as the additional post operative monitoring, the risk for serious deterioration in state of health is not negligible.

Manufacturer Narrative

As the device in question was not returned by the customer, an investigation on the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 2024-03-13.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.Based on the available information, it was revealed that the used loop was a single-use loop that had been resterilized.Therefore, this is most likely the reason for the reported failure.A corresponding warning can be found within the ifu.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can most likely be traced back to a usage-related failure.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 18384417
• MDR Text Key: 331291766
• Report Number: 9610617-2023-00402
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 011250-10
• Device Catalogue Number: 011250-10
• Device Lot Number: XO16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other