MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW OUTFLOW CASSETTE TUBING; ARTHROSCOPE

Catalog Number	0450000200
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
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 an expired product was used.
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: expired product.Probable root cause: hand control design; manufacturing/assembly error; unclear cleaning/sterilization instructions in hand control ifu; use error (s1, s3, s6, c1, c2, h4, h5, p12, p15, p17, p18, r1, r3); inadequate eo sterilization for tubing (manufacturing/assembly error); inadequate package seal strength for tubing (packaging design); inadequate package size/material selected for the tube-set weight and geometry (packaging design); leak in tubing; false date print leads to tube set used beyond sterility period; pressure sensor malfunction leading to higher spray from tubing; failure of check valve (also known as one-way valve or backflow valve).The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.81.
Event or Problem Description
It was reported that an expired product was used.

• Brand Name: CROSSFLOW OUTFLOW CASSETTE TUBING
• Common Device Name: ARTHROSCOPE
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17192923
• Report Number: 0002936485-2023-00630
• Device Sequence Number: 12615763
• Product Code: HRX
• UDI-Device Identifier: 37613327055215
• UDI-Public: 37613327055215
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K123441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 0450000200
• Device Lot Number: K22G136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 03/05/2024
• 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
• Patient Sex: Unknown