MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 5.5MM 30°, HD BARIATRIC AUTOCLAVABLE LAPAROSCOPE 45CM; SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number	0502513030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the failure mode was related to internal moisture and the moisture could not be wiped from the scope causing an unclear image.
Event or Problem Description
It was reported that the failure mode was related to internal moisture and the moisture could not be wiped from the scope causing an unclear image.
Additional Manufacturer Narrative
This scope was received at henke for evaluation.Based on the henke service record, the reported failure [foggy] was confirmed.According to henke: scope has been evaluated as a level 3 repair due to the distal damage, heavy scratches, dents, broken lenses and loose system.Probably root cause for this failure is: ¿ 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 returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PRECISION IDEAL EYES 5.5MM 30°, HD BARIATRIC AUTOCLAVABLE LAPAROSCOPE 45CM
• Common Device Name: SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9261049
• Report Number: 0002936485-2019-00490
• Device Sequence Number: 11516311
• Product Code: IZH
• UDI-Device Identifier: 07613327059182
• UDI-Public: 07613327059182
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993045
• 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): 01/28/2020

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: 0502513030
• Device Catalogue Number: 0502513030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1