MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5); LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL

Catalog Number 0220180517

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

Lighted ureteral stents were not working at the beginning of the procedure then suddenly started working.Although there was patient involvement, there was no adverse consequence.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: not working properly.Probable root cause: diode failure.Loose/disconnected cable.Cpu pc board defect.Power loss to diode.The device manufacture date is not known.Gtin: (b)(4).

Event Description

Lighted ureteral stents were not working at the beginning of the procedure then suddenly started working.Although there was patient involvement, there was no adverse consequence.

• Brand Name: PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)
• Type of Device: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6549207
• MDR Text Key: 74701768
• Report Number: 0002936485-2017-00433
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0220180517
• Device Lot Number: 1694987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1