MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA CONTROL UNIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1288010000

Device Problems Smoking (1585); Temperature Problem (3022)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that there was a thermal event.

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.

Manufacturer Narrative

Alleged failure: 1288 smoking in surgery room.It was plugged into a stryker cart.No camera head was plugged in.Did not look like damage to the cart plug.Update - no patient/user injuries.Device was warm to the touch.Heavy gray smoke.] the failure(s) identified in the investigation is consistent with the complaint record.Root cause: the root cause is an electrical component failure on the power supply board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a thermal event.

• Brand Name: PKG 1288HD CAMERA CONTROL UNIT
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15755297
• MDR Text Key: 303944427
• Report Number: 0002936485-2022-00639
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327063387
• UDI-Public: 07613327063387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1288010000
• Device Catalogue Number: 1288010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2011
• 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