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

Model Number 011160-10

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It was reported that the "device broke during procedure".The patient consequences remain unknown to date; negative consequences (e.G.If a part remained in patient) cannot be ruled out completely.

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).

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 2023-12-06.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, the failure description and similar complaints, we suspect a mechanical overload of the cutting loop which led to the reported breakage.Due to the fact, that the product has not been sent back, a final determination of the root cause is not possible.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: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 17782128
• MDR Text Key: 323849544
• Report Number: 9610617-2023-00266
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 846136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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