MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 5.5MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 30CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502503045
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
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 there was foggy image during the procedure.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: foggy confirmed failure: outer tube damaged (bent, dented) loose prism damaged distal cover glass 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 device manufacture date is not known.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported there was foggy image during the procedure.

• Brand Name: PRECISION IDEAL EYES 5.5MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 30CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15858929
• Report Number: 0002936485-2022-00700
• Device Sequence Number: 5391094
• Product Code: GCJ
• UDI-Device Identifier: 07613327059175
• UDI-Public: 07613327059175
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2023

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: 0502503045
• Device Catalogue Number: 0502503045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown