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

Catalog Number 0502555400

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

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 screw came off during procedure.The screw was successfully removed.

Event Description

It was reported that screw came off during procedure.The screw was successfully removed.

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
• Type of Device: 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
• MDR Text Key: 320406390
• Report Number: 0002936485-2023-00751
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 07613327059472
• UDI-Public: 07613327059472
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female