MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO URETERO-RENOSCOPE FLEX-XC

Model Number 11278VSU

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.The video uretero-renoscope flex-xc is damaged and is not working (no image is displayed on the screen).The leak test failed.The distal lens system shows residues on the cover glass and there is no light output on the light guide.The deflection is insufficient and the angle cover is perforated.As a consequence the scope is leaky.Inside of the housing are signs of remaining liquid and corrosion.An operator error due to erroneous reprocessing is assumed.The complaint records have been analyzed for similar cases.No indications for a systematic issue.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a uretero-renoscope flex-xc.It was reported that the device failed during the surgery.The surgery had to be canceled.No further information available.

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC
• Type of Device: VIDEO URETERO-RENOSCOPE FLEX-XC
• 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: 17079697
• MDR Text Key: 316697622
• Report Number: 9610617-2023-00671
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: MG
• PMA/PMN Number: K141250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

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: 11278VSU
• Device Catalogue Number: 11278VSU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• 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