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 Distortion (3000)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
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 blurry image during procedure.
Event or Problem Description
It was reported that there was blurry image during procedure.
Additional Manufacturer Narrative
The device manufacturer date is not known.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: lens was blurred.Probable root cause: incorrectly assembled optical train, damage to optical train, end of life wear-out, shipping damage, use error.The reported failure mode will be monitored for future reoccurrence.

• 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
• MDR Report Key: 12393291
• Report Number: 0002936485-2021-00479
• Device Sequence Number: 3421117
• Product Code: GCJ
• UDI-Device Identifier: 07613327062182
• UDI-Public: 07613327062182
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1