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

Catalog Number	0220180518
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that additional procedure was performed on the patient.
Event or Problem Description
It was reported that additional procedure was performed on the patient.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: piece broke off.Probable root cause: light fiber broken, connected to console incorrectly, non-compatible equipment configuration used, incorrect laser source/scope combination used, fiber damage during unpacking from pouch, damage during shipping/ handling, failures due to console, [illuminator - rsk10680 , output - infrared light], [aim console - rsk10975 , output - infravision output (aim only)], failures due to light source, (rsk10975 [l10] and rsk12346 [l11]).The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.

• Brand Name: IRIS URETERAL KIT
• Common Device Name: 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16383063
• Report Number: 0002936485-2023-00129
• Device Sequence Number: 5114455
• Product Code: FCS
• UDI-Device Identifier: 37613327174817
• UDI-Public: 37613327174817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0220180518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown