MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKERT INFRAVISION URETERAL KIT; LIGHT, CATHETER, FIBERPOPTIC, GLASS, URETERAL

Lot Number 1694987

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

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

Event Date 01/26/2017

Event Type  malfunction  

Event Description

Lighted ureteral stents were not working at the beginning of the procedure then suddenly started working.Route: urethral.Dates of use: (b)(6) 2017.Diagnosis or reason for use: diverticulitis.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: no.

• Brand Name: STRYKERT INFRAVISION URETERAL KIT
• Type of Device: LIGHT, CATHETER, FIBERPOPTIC, GLASS, URETERAL
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 6427255
• MDR Text Key: 70745609
• Report Number: MW5068582
• Device Sequence Number: 1
• Product Code: FCS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2018
• Device Lot Number: 1694987
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR