MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.8MM CANNULA, 1 ROTATING STOPCOCK; ACCESSORIES,ARTHROSCOPIC

Catalog Number 0747031530

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture 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 during an arthroscopy procedure, the surgeon noticed dried blood in the cavity of the knee which came out of the irrigation cannula.Although low risk of transmission as the cannula has been sterilized in decontamination, the unit bloods have been taken from the affected patient and the previous patient.The patient received hepatitis b vaccination due to the risk of infection.The instrument has been reprocessed.Although there was patient involvement, the procedure was completed successfully.

Manufacturer Narrative

"the reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: manufacturing controls: qc incoming and in-process inspections; manufacturing task instructions; instructions for use; design: minimize areas on scope where debris can be trapped or collect.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation." the product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that during an arthroscopy procedure, the surgeon noticed dried blood in the cavity of the knee which came out of the irrigation cannula.Although low risk of transmission as the cannula has been sterilized in decontamination, the unit bloods have been taken from the affected patient and the previous patient.The patient received hepatitis b vaccination due to the risk of infection.The instrument has been reprocessed.Although there was patient involvement, the procedure was completed successfully.

• Brand Name: 5.8MM CANNULA, 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5272484
• MDR Text Key: 32861138
• Report Number: 0002936485-2015-01102
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0747031530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other