MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 1488 HD 3-CHIP CAMERA HEAD, C-MOUNT - INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1488210105I
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foggy image.
Additional 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.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: upon inspection, we were unable to confirm any internal moisture contamination or clouding.Although there was an airtight failure at the base of the cable (head side) , we judge that there is no direct causal relationship to this incident.When the cable is replaced or repaired, we will replace the dehumidifying material inside the head free of charge.Processing work details: replacement of defective parts (cables), operation/function inspection, and quality inspection tests.Probable root cause: cables; connectors; digital board; power supply; filter / fuse; ac inlet board; main board; transition board; fiber board; intermittence between transition board and ch connector; software; scope ; light source; camera head; coupler; 1488 & 1588 extension cable; intermittence while using rf devices; problem toggling light source or from camera head; connected monitors; leaking; use error; poor grounding; electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: 1488 HD 3-CHIP CAMERA HEAD, C-MOUNT - INTERNATIONAL KIT
• 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: 18965376
• Report Number: 0002936485-2024-00263
• Device Sequence Number: 7906421
• Product Code: GCJ
• UDI-Device Identifier: 07613327061055
• UDI-Public: 07613327061055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132785
• 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): 07/03/2024

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: 1488210105I
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• 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