MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR ELECTRODE, 1.3MM

Model Number	28161SF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not yet returned for investigation, therefore the root cause is not yet determined.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported: "during an endoscope ventriculoscopy, use of a 28161 sf coagulant forceps that may have entered the working channel of the endoscope but the end of which broke during removal.This extremity was impossible to recover because it was inaccessible by the lateral ventricle.Obligation to convert to open surgery and retry and failure to recover material.".
Additional Manufacturer Narrative
According to customer's information, the affected product could not be sent for further investigation.With reference to similar cases, the most probable root cause of broken electrode is that it broke due to high mechanical stress caused by the customer.As a result of an analysis of similar cases, no product related malfunction could be determined.Since no systemic issue was determined; no corrective action is required at this time.According to the instruction for use, chapter 4, there is a warning that a mechanical overload can lead to injury to the patient.

• Brand Name: BIPOLAR ELECTRODE, 1.3MM
• Common Device Name: BIPOLAR ELECTRODE, 1.3MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11863542
• Report Number: 9610617-2021-00046
• Device Sequence Number: 16942382
• Product Code: GWG
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 28161SF
• Device Catalogue Number: 28161SF
• Device Lot Number: VU01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability