MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 1288 CCU INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1288010000

Device Problem Smoking (1585)

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

Event Date 05/25/2022

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 device was smoking.

Event Description

It was reported that the device was smoking.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: smoke came out of the column, we could not identify from which material.Probable root cause: product shorts and generates a small puff of smoke outside of surgery.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: 1288 CCU INTERNATIONAL KIT
• 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: 14679357
• MDR Text Key: 294384837
• Report Number: 0002936485-2022-00320
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327063387
• UDI-Public: 07613327063387
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1288010000
• Device Catalogue Number: 1288010000I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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