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

Model Number PC9000

Device Problems No Device Output (1435); Unintended Electrical Shock (4018)

Patient Problems Shock (2072); Electric Shock (2554)

Event Date 10/11/2021

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 experienced electric shock.

Event Description

It was reported that the user experienced electric shock.

Manufacturer Narrative

Alleged failure: "it was reported that "(engineer) installed it on the stack first thing this morning, completed an electrical safety test and function check.On pre-use check the theatre staff found that the loan pc9001, sn (b)(6) would not switch on.Initial reporter (staff at account) was called to troubleshoot, as they inspected the device it gave them quite a significant electric shock.They can also confirm it does not switch on."" probable root cause/s: as reported, vpi could not power up.The failure was caused by a power supply failure.The device was returned for investigation and the reported failure mode was reproduced.The reported failure mode will be monitored for future re occurrence.Manufacture date is not known.

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; 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: 12789401
• MDR Text Key: 281524766
• Report Number: 0002936485-2021-00620
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Model Number: PC9000
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 12/22/2021
• 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