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

Model Number	0502-404-070
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
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 the image was foggy during use.
Event or Problem Description
It was reported the image was foggy during use.
Additional Manufacturer Narrative
Alleged failure: both serial numbers had continuous fogging during use.Both camera and scope were bone dry before case and were wiped down again during use.Moisture is likely getting in between c mount 1588 camera and scope.(b)(4) case number (b)(4) the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as the complaint could not be confirmed.Nc2245012 was opened for the occurrence breach which had occurred for the precision ie 4k arthroscopes under the "fogging" complaints.There is still an ongoing investigation to determine the root cause of the fogging complaints associated with the occurrence breach.Additionally, it was noticed that when moisture is introduced to the proximal area of the scope prior to forming a seal with the camera head, fogging does occur.Another observation seen on the proximal o-ring was that debris sheds off of the o- ring when connected and tightened to a camera head.This was noticed in conjunction with the investigation.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PRECISION IE 4K C-MOUNT 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: 8992874
• Report Number: 0002936485-2019-00384
• Device Sequence Number: 16674097
• Product Code: HRX
• UDI-Device Identifier: 07613327416473
• UDI-Public: 07613327416473
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/19/2020

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: 0502-404-070
• Device Catalogue Number: 0502404070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1