MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RIGID ENDOSCOPE WORKING GUIDE; WORKING ELEMENT, BIPOLAR

Model Number	27040DB
Medical Device Problem Codes	Energy Output Problem (1431); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with a working element.There is no failure description available.According to the information received there was an additional medical intervention necessary due to the incident reported and a poor haemostasis occurred.Due to limited information and the information mentioned above this case was rated deemed reportable.Additional information was already requested.If additional information becomes available this report will be updated unsolicited.
Additional 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).
Additional Manufacturer Narrative
Additional information is provided in section d10 to add the associated product.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was further reported that the defective bipolar electric cable had smoke coming out of the handle holder and intermediate part of the device was overheating.Hemostasis was less effective, with bleeding persisting despite theoretically effective coagulation.Hematuria occurred.Bleeding was stopped using a monopolar resector instead.There is no permanent or temporary impairment for the patient.
Additional Manufacturer Narrative
Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
According to the information received from the customer, there was poor hemostasis and poor cutting quality during the operation with the items.In addition, the customer reported that between the article 27040db working element, bipolar and the connected bipolar electric cable (manufacturer, article number unknown) there was an overheating and smoke development from the cable.It is assumed that due to residual moisture or moisture intrusion a short circuit occurred between the cable connector and the working element.The short circuit may have led to the described overheating and smoke development.The moisture intrusion is assumed to be caused due to improper handling.A more detailed investigation cannot be carried out without returned articles.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: RIGID ENDOSCOPE WORKING GUIDE
• Common Device Name: WORKING ELEMENT, 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, CA 90245
• MDR Report Key: 17738497
• Report Number: 9610617-2023-00255
• Device Sequence Number: 6634368
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 4048551075500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: XR114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 10/20/2023; 12/18/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 09/21/2023; 10/31/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UH300 - AUTOCON III 300,220-240V.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown