MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 5MM 30A LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502539030
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
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.
Additional Manufacturer Narrative
The device manufacture date is not known.This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service record attached, the reported failure "blurry" was confirmed.According to henke: scope evaluated as a level 3.Dents, deep distal tip/fiber damage, loose optics, particulate under distal cover glass, scratches on needle, residue on external optics and missing paint.The complaint for ¿blurry¿ has been confirmed and is due to customer use and handling.Probably root cause for this failure is: 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.
Event or Problem Description
It was reported that there was blurry image.

• Brand Name: HD 5MM 30A LAPAROSCOPE, AC
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12084329
• Report Number: 0002936485-2021-00345
• Device Sequence Number: 13674885
• Product Code: GCJ
• UDI-Device Identifier: 07613327059427
• UDI-Public: 07613327059427
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/31/2021

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: 0502539030
• Device Catalogue Number: 0502539030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1