MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 5MM 0° LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502539010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
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 scope had a cloudy image during use, procedure completed successfully with a replacement scope.
Additional Manufacturer Narrative
Alleged failure: cloudy.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.The device manufacturer date is not known.
Event or Problem Description
It was reported the scope had a cloudy image during use, procedure completed successfully with a replacement scope.

• Brand Name: HD 5MM 0° LAPAROSCOPE, AC
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8608027
• Report Number: 0002936485-2019-00204
• Device Sequence Number: 2004054
• Product Code: GCJ
• UDI-Device Identifier: 07613327059403
• UDI-Public: 07613327059403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910132
• 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): 08/12/2019

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: 0502539010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1