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

Model Number 011050-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2024

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 device broke in the 75 year old patient during surgery.The broken pat was not recovered and is suspected to be in the patient.The general anesthesia was extended.

Manufacturer Narrative

The reported product was returned to the manufacturer for a thorough investigation on 2024-02-16.The investigation of the product was completed on 2024-05-29.Upon analysis, it was found that the working electrode had broken off and was missing.Examination of the broken surface revealed characteristics consistent with a forced break, specifically indicating a ductile fracture.This type of break suggests that the material underwent significant deformation before separating, typically due to an applied force.Considering the nature of the damage, it is most likely that the root cause of the failure is the exposure of the electrode to excessive force during the application process.This excessive force could have been applied inadvertently or as a result of improper handling or usage conditions.Internal karl storz reference number: (b)(4).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• 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 90245
• MDR Report Key: 18669647
• MDR Text Key: 334950199
• Report Number: 9610617-2024-00030
• 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
• Report Date: 02/08/2024

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: 011050-10
• Device Catalogue Number: 011050-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• 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