MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE IRIS URETERAL KIT; LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL

Model Number 0220180518

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

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

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was conversion to open procedure.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, however, the light source under complaint (b)(4) involved in this event was received, and investigated.The conclusion of the light source investigation indicates that the failure reported was due to a light source failure.Alleged failure: stents shut off.Probable root cause: diode failure.Loose/disconnected cable.Cpu pc board defect.Power loss to diode.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported that there was conversion to open procedure.

• Brand Name: IRIS URETERAL KIT
• Type of Device: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10111173
• MDR Text Key: 193401851
• Report Number: 0002936485-2020-00222
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 07613327174816
• UDI-Public: 07613327174816
• Combination Product (y/n): N
• PMA/PMN Number: K151243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0220180518
• Device Catalogue Number: 0220180518
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1