MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1788 CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1788010000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: per the rep: obf giving warning of overheating and immediately shutting down.[update - unable to confirm how warm the device was becoming.The device shut off immediately.The alert happened immediately after the camera was plugged in.] the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: ccu conforms to specifications.The most probable root cause of the issue reported could be a camera head used along with the ccu at the customer's facility since this error (e-05) is related to camera head overheating.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a thermal event.
Event or Problem Description
It was reported that there was a thermal event.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: PKG, 1788 CAMERA CONTROL UNIT (CCU)
• Common Device Name: 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: 20091846
• Report Number: 0002936485-2024-00623
• Device Sequence Number: 7847612
• Product Code: GCJ
• UDI-Device Identifier: 07613327580013
• UDI-Public: 07613327580013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K230605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1788010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Patient Sex: Unknown