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

Model Number	PC9000
Medical Device Problem Codes	Image Display Error/Artifact (1304); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the light lead was very hot, indicating a thermal event.There were no adverse consequences as a result.
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.
Additional Manufacturer Narrative
The device manufacturer date is not known.Alleged failure: "it was reported to the rep that "the light was very dark and poor in a case." the rep has now advised "couldn¿t replicate the issue testing but i did find the light lead was very hot after i removed it from the vpi." probable root cause/s: product was not returned to stryker endoscopy.Based on the reported symptoms, reported issue can be caused by a number of electrical and/or mechanical issues affecting both the light cable connection between the vpi and camera and various electrical components responsible for powering the rgb leds/nir laser diode.Probable root cause remains unknown but can include the following: 1) intermittent led pca/nir laser diode failure: a malfunction in any of the vpi components responsible for powering the leds and nir laser diode leading to power loss may result in reduced illumination.2) light cable not completely inserted: if the light cable was incompletely inserted or partially pulled out during a procedure, it can reduce the amount of light transmitted out the scope/illumination aperture of the camera.3) spy phi stuck filter error: if using a spy phi imager, a stuck filter error caused by the top vis filter failing to retract will cause overlay, csf and white light imaging modes to be very dark due to filter excluding most visible light.4) residue on light post of scope: if the junction between the light cable and scope is contaminated with residue, light output at the tip may be reduced.This complaint investigation was closed based on the device not received.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the light lead was very hot, indicating a thermal event.There were no adverse consequences as a result.

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer Contact: kelsey barla ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15478593
• Report Number: 3012345110-2022-00008
• Device Sequence Number: 20139872
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/12/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown