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

Model Number PC9000

Device Problem Electro-Static Discharge (2149)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Date 12/02/2022

Event Type  malfunction  

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 Description

It was reported that the user received an electrical shock.

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 Description

It was reported that the user received an electrical shock.

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Type of Device: 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16098456
• MDR Text Key: 306680072
• Report Number: 3012345110-2023-00001
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K150956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PC9000
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other