MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO FLEXIBLE CYSTOSCOPE; FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW

Model Number R11272VHK

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

The affected article has been requested for investigation by the manufacturer and is in transit to the manufacturing site in germany.

Event Description

The reported event happened in canada.According to the received information the image of a flexible video cystoscope hd-view came up when the scope was plugged in but when they went to use cauterization with a bugbee electrode, as soon as the urologist activates the electrode, the image cut out.No injury to the patient, user or third was reported.

Manufacturer Narrative

Per the sales representative, the product was not returned; therefore an evaluation and root cause analysis could not be preformed.There has been no documented instances of this defect occurring on the 11272vh hd cystoscope.Due to the product not being returned, an evaluation was not preformed therefore the hazard could not be confirmed by kse.However, an iaf has been initiated to determine if a capa or additional actions are needed.The item in question was returned to the manufacturer.The evaluation is not complete but the new estamiated completion date for this is aproximently early march 2023.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

It was brought to our attention that information regarding the return of the product to the manufacturer was incorrect.The product was not returned for eveluation.Furthermore, the manufactuing number for this case is incorrect and should refelct the kse manufactuign number 1221826 instead of the kst manufacturing number 9610617.

Manufacturer Narrative

Per trending, kse has not seen previous instances of this defect occurring on the 11272vh hd cystoscope but has seen this defect on a scope of a different design.As a result of the defect being seen on scopes of a different design and the absence of the product being returned, it was determined kse would perform testing on this model scope, over a set period of time, in an effort to determine if the defect would be seen on product of the same design.No issues were noted.The manufacturing number for this case is incorrect and should reflect the kse manufactuign number 1221826.Instead of the kst manufacturing number 9610617.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

This report is to correct the aware date of last supplemental submission 22-249_sup3.The correct aware date was january 1, 2023 and not january 12, 2023.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The reported image loss could not be duplicated by kse's internal testing.Additional testing of outgoing products also yield no occurrences of this failure mode.Risk management file has been reviewed and this hazard is covered.Customer did not report a patient injury, therefore no further action will be taken.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: VIDEO FLEXIBLE CYSTOSCOPE
• Type of Device: FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW
• 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: 15261771
• MDR Text Key: 298410281
• Report Number: 9610617-2022-00249
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R11272VHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 11/17/2022; 12/19/2022; 01/12/2023; 01/02/2023; 06/08/2023
• Supplement Dates FDA Received: 11/19/2022; 12/19/2022; 01/13/2023; 05/03/2023; 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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