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

Model Number 27040DB

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2023

Event Type  Injury  

Event 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.

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).

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 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.

Manufacturer Narrative

Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).

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
• Type of Device: 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
• MDR Text Key: 323310702
• Report Number: 9610617-2023-00255
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 4048551075500
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 10/20/2023; 12/18/2023
• Supplement Dates FDA Received: 09/21/2023; 10/31/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UH300 - AUTOCON III 300,220-240V.
• Patient Outcome(s): Other