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

Catalog Number 0220180518

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/09/2019

Event Type  malfunction  

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 the stent was not fully lighting up.

Manufacturer Narrative

Alleged failure: had an odd issue with some iris stents.Back to back cases, different rooms, different towers but both a 1588/l10 setup.The stents were inconsistent.I had to constantly plug/unplug them to get them to illuminate.Both might show up, both may be off, one may be off, one bright, etc.Per our phone conversation, i troubleshot it thoroughly in the room.I have two more stents from that box i can send back.During case- no pt harm or delay- case was completed.Lot ¿ 2302231.Rma (b)(4) salesforce case number (b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be the l10 console the u-kit was connected to had a broken laser diode or damaged emitting fiber during insertion.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

Event Description

It was reported that the stent was not fully lighting up.

• 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: 8861264
• MDR Text Key: 153284116
• Report Number: 0002936485-2019-00327
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 37613327174817
• UDI-Public: 37613327174817
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0220180518
• Device Lot Number: 2302231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1