MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 10MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502103045
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
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 that there was blurry image.
Event or Problem Description
It was reported that there was blurry image.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: poor visual field.Probable root cause: incorrectly assembled optical train; damage to optical train; end of life wear-out; shipping damage; use error.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.

• Brand Name: PRECISION IDEAL EYES 10MM 45°, 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: 13170815
• Report Number: 0002936485-2022-00005
• Device Sequence Number: 4385547
• Product Code: GCJ
• UDI-Device Identifier: 07613327062144
• UDI-Public: 07613327062144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K993045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 0502103045
• Device Catalogue Number: 0502103045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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