MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 10MM 30A LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502859030
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Codes	Menorrhagia (4508); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
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.
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.The failure mode will be monitored for future reoccurrence.The technical service report is attached (see communication log), and indicates: replacement of damaged optics type probable root cause: ¿ incorrectly assembled optical train ¿ damage to optical train ¿ end of life wear-out ¿ shipping damage ¿ use error.

• Brand Name: HD 10MM 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: 12076668
• Report Number: 0002936485-2021-00340
• Device Sequence Number: 4169587
• Product Code: GCJ
• UDI-Device Identifier: 07613327060171
• UDI-Public: 07613327060171
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 0502859030
• Device Catalogue Number: 0502859030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1