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

Model Number 0502711530

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/14/2022

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 there was an incomplete procedure.

Event Description

It was reported that there was an incomplete procedure.

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
• Type of Device: 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
• MDR Text Key: 291302348
• Report Number: 0002936485-2022-00119
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327062793
• UDI-Public: 07613327062793
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT DEVIC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 05/11/2022
• 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