MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 10MM 30°, HD AUTOCLAVABLE LAPAROSCOPE 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502103030
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
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 that there was foggy image.
Event or Problem Description
Additional information confirmed that the moisture could be wiped away therefore making the reported event of foggy image not reportable.
Additional Manufacturer Narrative
This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for repair, but was not evaluated therefore the reported failure "constant fogging of the optics" was not confirmed.According to henke: outer tube damaged, distal tip.Distal tip damaged.Outer tube body / light post.Body damaged.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 reported failure mode will be monitored for future reoccurrence.Additional information confirmed that the moisture could be wiped away therefore making the reported event of foggy image not reportable.Manufacture date is not known.

• Brand Name: PRECISION IDEAL EYES 10MM 30°, HD AUTOCLAVABLE LAPAROSCOPE 33CM
• 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: 15330019
• Report Number: 0002936485-2022-00496
• Device Sequence Number: 15031395
• Product Code: GCJ
• UDI-Device Identifier: 07613327062182
• UDI-Public: 07613327062182
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 0502103030
• Device Catalogue Number: 0502103030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/31/2022
• 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