MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 2.8MM CANNULA WITH 1 ROTATING STOPCOCK; ACCESSORIES, ARTHROSCOPIC

Model Number	0502711530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
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 there was an incomplete procedure.
Event or Problem Description
It was reported that there was an incomplete procedure.
Additional Manufacturer Narrative
Alleged failure: on (b)(6) 2022, having a patient anesthetized and preparing to start the surgery, they assembled the instruments and realized that the body of the cannula detached from its base.[update - the problem was discovered before starting the procedure, when they were preparing the material on the arsenal table.The patient was only anesthetized but no incision had been made.The device detach outside the patient.The procedure could not be performed due to lack of the instrument and the patient was woken up.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be rough handling during sterilization, product use, and/or product transport.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: 2.8MM CANNULA WITH 1 ROTATING STOPCOCK
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: 13758714
• Report Number: 0002936485-2022-00119
• Device Sequence Number: 5149463
• Product Code: NBH
• UDI-Device Identifier: 07613327062793
• UDI-Public: 07613327062793
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT DEVIC
• 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): 05/11/2022

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 Model Number: 0502711530
• Device Catalogue Number: 0502711530
• Device Lot Number: 1607855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/11/2022
• 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: Unknown