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

Catalog Number	0220180518
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign material inside the sterile packaging.
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 there was foreign material inside the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: it was noticed by the staff so it was not opened.There were small black flakes inside the sterile package.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be manufacturing.A non-conformance report was created ((b)(4)) for the "product" and will be sent to the vendor for further analysis.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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: 16761973
• Report Number: 0002936485-2023-00317
• Device Sequence Number: 5992353
• Product Code: FCS
• UDI-Device Identifier: 37613327174817
• UDI-Public: 37613327174817
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0220180518
• Device Lot Number: 8061177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown