MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR, LONGITUDINAL; ENDOSCOPIC ELECTROSURGICAL ELECT

Model Number 011156-10

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) that they had experienced multiple loop breakages.I visited on (b)(6) and spoke to the customer directly.He reported that they converted from holep (using a laser) to a turp due to a bleed and used 3 loops and 1 ball.The procedure took 3 hours though i couldn't ascertain as to how long the resection part was.Upon questioning the patient had not had any previous prostate surgery and started as a standard case.He was not sure if it was a large prostate, i would assume it would have been.The loops failed inside the patient and had to be removed endoscopically.The autocorrect setting were on standard and not changed during the case.The nurse was unsure how often the malfunction occurs with the product.After converting from holep to bipolar.Cutting loops and roller balls for bipolar diathermy started breaking and/ or melting down.We finished the procedure.After this, he was transferred to a different hospital where they extracted more metal bits from his prostate.The patient was fine and was discharged from the hospital.

Manufacturer Narrative

The working electrode is broken off on the power supply side.Both, neutral and working electrodes show molten holes.The power-supplying wire of the working electrode is molten away several millimeters.Device history records (dhr), and recent product or process changes were reviewed.According to the results of the device history review, there was no indication of a manufacturing failure.The most probable root cause is user-related.The molten electrodes - working and neutral indicate that the working electrode got bent towards the neutral electrode and created a shortcut which resulted in excessive heat causing the parts to melt.The force necessary for this is not required during intended use.Internal karl storz reference number: (b)(4).

• Brand Name: ELECTRODE, BIPOLAR, LONGITUDINAL
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECT
• 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: 15826951
• MDR Text Key: 303937848
• Report Number: 9610617-2022-00312
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 011156-10
• Device Catalogue Number: 011156-10
• Device Lot Number: 838654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other