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

Model Number	PC9000
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Electric Shock (2554)
Date of Event	12/02/2022
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 the user received an electrical shock.
Additional Manufacturer Narrative
The device manufacturer date is not known.Alleged failure: "sent it into a hospital on loan and the engineer who went to est and received an electric shock.It subsequently did not pass the est¿s the hospital engineer tried to complete.Customer sent two of our own engineers in who tried est¿s on different testing machines and all of them did not pass." probable root cause/s: product was not returned to stryker endoscopy.Based on the reported symptoms, probable root cause can include the following: 1) faulty electrical grounding.2) faulty power supply.The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the user received an electrical shock.
Additional Manufacturer Narrative
Alleged failure: "sent it into a hospital on loan and the engineer who went to est and received an electric shock.It subsequently did not pass the est¿s the hospital engineer tried to complete.Customer sent two of our own engineers in who tried est¿s on different testing machines and all of them did not pass." probable root cause/s: product was not returned to stryker endoscopy.Based on reported circumstances of incident, probable root cause is due to use of a non-applicable electrical safety test (est) method on the vpi with a spy phi imager attached.The reported est protocol was in accordance with iec 60601 class 1 type bf with 1 applied part, which is only applicable for medical devices which come into physical contact and electrical contact with the patient during use.As the spy phi device does not come into direct contact with the patient under all intended use scenarios, this test is not a valid method for evaluating the electrical safety compliance of this device.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.Manufacture date is not known.
Event or Problem Description
It was reported that the user received an electrical shock.

• 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; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16098456
• Report Number: 3012345110-2023-00001
• Device Sequence Number: 6816830
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• 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): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 12/06/2022
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/10/2023; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown