MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION AC 3-CHIP CAMERA CONTROL UNIT (CCU) - INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0700010000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was loss of image.
Event or Problem Description
It was reported that there was loss of image.
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: "p/n #: 0700010000i s/n: (b)(6).Summary of evaluation: e2 error ¿ faulty digital board assembly replaced the digital board assembly, updated the software and completed qip device will ship back to the customer today." probable root cause: software, front board, digital board, lcd touch panel, sidne or sdc communication, power supply, filter / fuse, connectors, manufacturing/ service nonconformity, degradation from cleaning, use error, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.Manufacture date is not known.

• Brand Name: PKG, PRECISION AC 3-CHIP CAMERA CONTROL UNIT (CCU) - 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: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12858161
• Report Number: 0002936485-2021-00668
• Device Sequence Number: 5984650
• Product Code: GCJ
• UDI-Device Identifier: 07613327137354
• UDI-Public: 07613327137354
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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 Model Number: 0700010000
• Device Catalogue Number: 0700010000I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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