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

Model Number	0502859030
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
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 a blurry image.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The device(s) was not received for investigation at stryker endoscopy because it was repaired locally in poland; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.The technical service report is attached (see communication log), and indicates: broken optics the reported event involving this failure and device could have been caused by: incorrectly assembled optical train.Damage to optical train.End of life wear-out.Shipping damage.Use error.Manufacture date is not known.
Event or Problem Description
It was reported that there was a blurry image.

• 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: 10396055
• Report Number: 0002936485-2020-00334
• Device Sequence Number: 3105311
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 07/15/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1