MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K EYEPIECE ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK

Model Number	0502-444-070
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported image was foggy during procedure.Additional information confirmed a replacement was used to complete the procedure successfully.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence .The device manufacture date is not known.Alleged failure: foggy.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.
Event or Problem Description
It was reported image was foggy during procedure.Additional information confirmed a replacement was used to complete the procedure successfully.
Additional Manufacturer Narrative
Alleged failure: foggy 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 product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence .
Event or Problem Description
Per additional information received, the fogging could be wiped off.The same device could be used to complete the procedure.The foggy camera head and scope may cause user inconvenience but did not result in any adverse consequences.Therefore making this event not reportable.

• Brand Name: PRECISION IE 4K EYEPIECE ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9082973
• Report Number: 0002936485-2019-00403
• Device Sequence Number: 16174860
• Product Code: HRX
• UDI-Device Identifier: 07613327405910
• UDI-Public: 07613327405910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183470
• 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,Followup
• Report Date (Section B): 03/17/2020

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: 0502-444-070
• Device Catalogue Number: 0502444070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 08/22/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 11/08/2019; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1