MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, BIOPSY CUP 5FR SEMI FLEX; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number	0502555400
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
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 screw came off during procedure.The screw was successfully removed.
Event or Problem Description
It was reported that screw came off during procedure.The screw was successfully removed.
Additional Manufacturer Narrative
Alleged failure: cib, lisa, biomed,broken, po, sent ack letter.Update: during the procedure we were using the cup when they stopped working and a screw came into the field of view.The screw came off inside the patient¿s uterus during the procedure.The procedure was completed and the screw was retrieved.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be rough handling and/or contact with metal objects during processing and sterilization, causing components to become loose or broken.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, BIOPSY CUP 5FR SEMI FLEX
• Common Device Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 17447395
• Report Number: 0002936485-2023-00751
• Device Sequence Number: 7260775
• Product Code: FAJ
• UDI-Device Identifier: 07613327059472
• UDI-Public: 07613327059472
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 0502555400
• Device Lot Number: 2241447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female