MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE VIDEO PROCESSOR/ILLUMINATOR (VPI); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	PC9000
Medical Device Problem Codes	Poor Quality Image (1408); Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
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 loss of image.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
Alleged failure: "our distributor reported that" the nurse in charge of the hospital stated that they lost sight during the operation.He stated that during the viewing, the screen turned into a completely green screen error.During the observation in the hospital, it was observed that the imaging system and the energy unit were at the same connection point.Although the problem seems to be resolved after the system is connected to a different power outlet, the display system continues to give a green screen error." probable root cause: no fault found on vpi.The reported failure mode was caused by internal damage to the camera cable as investigated under pr#(b)(4).The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.81.

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11387790
• Report Number: 0002936485-2021-00114
• Device Sequence Number: 3359775
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: PC9000
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1