MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE DIGITAL URETEROSCOPE (STANDARD); URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0502110111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 03/21/2014

Event Type  Injury  

Event Description

It was reported that during a trial the ureter ruptured when being taken out of the patient.The original procedure was not completed as repairing the damage had to be done.

Manufacturer Narrative

The reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: chipping/peeling of other components, components from scope tip falling off, glue degradation.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.

Event Description

It was reported that during a trial the ureter ruptured when being taken out of the patient.The original procedure was not completed as repairing the damage had to be done.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

Product was received at stryker endoscopy.The unit was then sent to vsi for a full investigation.The customer's complaint of the insertion tube being damaged has been confirmed.During the estimation it was found that the light guide fibers, angle section and angle wires are broken.The scope has no image and the channel is leaking.Replacements include the final insertion tube, ferrule, adaptor, sealing cap and vent cap.Probable root cause: traumatic handling.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.       .

Event Description

It was reported that during a trial the ureter ruptured when being taken out of the patient.The original procedure was not completed as repairing the damage had to be done.

• Brand Name: DIGITAL URETEROSCOPE (STANDARD)
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3747124
• MDR Text Key: 4860300
• Report Number: 0002936485-2014-00223
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0502110111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2014
• Initial Date FDA Received: 04/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/27/2014; 03/23/2015
• 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: Reuse
• Patient Sequence Number: 1