MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG FLEX-X; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 11278VUA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2016

Event Type  malfunction  

Event Description

During cleaning and processing of digital ureteroscope, technician noted excessive leakage greater than 10mmhg/second from scope.Scope isolated and sent to biomedical engineering for inspection and communication with manufacturer.Biomed confirmed greater than 10mmhg/sec pressure drop on test gauge indicating major leak in endoscope.This is a reoccurring report on this particular failure with these digital scopes.Reference previous medwatch report.Manufacturer response for ureteroscope, digital, flex (per site reporter): this is an on-going issue with these failures.Manufacturer requesting device sent in for evaluation of failure.Biomedical requesting formal report of failure to be returned for risk management evaluation and to be placed into record.

• Brand Name: FLEX-X
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 600 corporate pointe; culver city CA 90230
• MDR Report Key: 6212805
• MDR Text Key: 63533819
• Report Number: 6212805
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/27/2016

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: Physician
• Device Model Number: 11278VUA
• Device Catalogue Number: 11278VUA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2016
• Device Age: 10 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1