MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 4MM A/C ARTHROSCOPE

Catalog Number	0502477011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported scope was foggy, replacement scope used to complete procedure.
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.Please note that the initial report's type of reportable event was malfunction; per additional information confirmed that the issue was noticed before the case was started.An arthroscope having foggy image noticed before the case was started may cause user dissatisfaction but is not likely to result in any safety concerns to the patient or user.The procedure was completed successfully and no adverse consequences were reported.It does not seem likely that adverse consequences would result if it were to recur.Therefore making this event not reportable.
Event or Problem Description
Additional information confirmed that the issue was noticed before the case was tarted.An arthroscope having foggy image noticed before the case was started may cause user dissatisfaction but is not likely to result in any safety concerns to the patient or user.The procedure was completed successfully and no adverse consequences were reported.It does not seem likely that adverse consequences would result if it were to recur.Therefore making this event not reportable.

• Brand Name: PKG, 4MM A/C ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8758311
• Report Number: 0002936485-2019-00276
• Device Sequence Number: 1590936
• Product Code: HRX
• UDI-Device Identifier: 07613327059199
• UDI-Public: 07613327059199
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• 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): 08/22/2019

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 Catalogue Number: 0502477011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1