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

Model Number 011168-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 12/29/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with the product.The loop of the device broke off intraoperatively.According to the complaint description, the loop broke off inside the patient.The broken fragment is missing and was not found.The patient was x-rayed and all surgery teams were in agreement that the product is no longer in the patient.Irrigation was done as well.According to the surgeon, there is no evidence of fragment retention, the surgeon is confident that the fragment had been removed by irrigation.The patient recovered well.Additional patient information is not available.

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

According to the information received the device was already discarded and an investigation of the device itself is not possible.The device history record did not show any deviation and the product passed the final inspection.Reviewing similar complaints shows no indication of an increase/trend in this reported issue.This is the second complaint of this batch and from the same end customer.This leads to the exemption that it is the same problem as in a similar complaint before.Nevertheless, this device was discarded, and it is the same failure as in an earlier complaint that happened soon after the earlier complaint.It can be assumed that the electrode was mechanically overloaded which led to a forced breakage and a manufacturing-related error can therefore be excluded.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, STERILE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16227809
• MDR Text Key: 307941196
• Report Number: 9610617-2023-00020
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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 Operator: Health Professional
• Device Model Number: 011168-10
• Device Catalogue Number: 011168-10
• Device Lot Number: 839166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/23/2023
• 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
• Patient Outcome(s): Other