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

Model Number 011160-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.

Event Description

Manufacturer incident report # (b)(4) received from the factory in germany: it was reported that there was an issue with the product electrode, bipolar.The cutting element of the loop and one of the yellow arms that support this broke off intraoperatively.According to the complaint description the breakage was recognized when reintroducing the loop following a bladder wash-out.In addition, the electrode was failing to emit any power due to the missing part.A thorough search of the bladder under vision was done, x-rayed the patient from multiple views, and also searched the entire surrounding area, but it was not possible to locate the missing piece.The surgeon was satisfied that the missing part was not present in the bladder or urethra; therefore, the procedure was completed, and the patient was taken to recovery as planned.It is possible that the missing part was perhaps removed via the irrigation out-flow or into a bucket following a bladder washout before noticing it was broken.The missing part may remain in the patient's body.Surgery was prolonged for 30 minutes.

Manufacturer Narrative

Visual examination of the affected device revealed that the cutting electrode is broken at the exit of the insulation on the current delivery side.The broken part is missing.The fracture surface shows little melting areas.Furthermore, the melting areas indicate that a high-frequency current was activated when the break occurred.The remaining areas show a ductile appearance which indicates a break by mechanical overload.The device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications.Based on the investigation results, the root cause of the reported issue can be traced back to a usage-related failure.

Event Description

Internal complaint number: (b)(4).

• Brand Name: BIPOLAR ELECTRODE
• 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: 15392981
• MDR Text Key: 299591529
• Report Number: 9610617-2022-00259
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048438005408
• UDI-Public: 4048438005408
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K961702
• 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,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 838163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: No
• 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