MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30°, 140MM, SPEED-LOCK

Model Number 0502-404-030

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  Injury  

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 the procedure was converted to open.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: fogging and condensation.Probable root cause: laser welding seal failure, distal/proximal window solder failure, damage to optical train, damage to needle, damage to distal or proximal windows, moisture intrusion, end of life wear-out, environmental disturbance: endoscope colder than dew point, environmental disturbance: fluid entrapment between the coupler and eyepiece, junction (eyepiece only), use error.The device manufacture date is not known.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the procedure was converted to open.

• Brand Name: PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30°, 140MM, SPEED-LOCK
• Type of Device: ARTHROSCOPE
• 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: 12800934
• MDR Text Key: 280683495
• Report Number: 0002936485-2021-00622
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327416497
• UDI-Public: 07613327416497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183470
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502-404-030
• Device Catalogue Number: 0502404030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2021
• 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