MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1788 4K COUPLER C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1788210105
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Image Orientation Incorrect (1305); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was inverted image.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was inverted image.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.Multiple attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: error message probable root cause: - ccu software failure - usb port - usb cable - device control - fpga fan - temperature sensors - main board - prism the reported failure mode will be monitored for future reoccurrence.
Additional Manufacturer Narrative
Please note we are discontinuing the current practice of filing malfunction medical device reports (mdrs) for reported complaints related to inverted images on stryker endoscopy's endoscopic camera systems and devices.The camera systems are an endoscopic camera system that is used to produce live video in the surgical field during endoscopic surgical procedures.The system is sensitive in the visible and infrared spectrum.The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes, which are attached to the camera head.The system consists of a camera console and a camera head with an integral cable that connects to the console.A coupler is also available for attaching a scope to the camera head.This malfunction has not caused or contributed to any deaths or serious injuries in the last two years.Based on the information provided, it has been determined that this malfunction is unlikely to cause or contribute to death or serious injury should the malfunction recur.Therefore, we intend to discontinue filing mdrs for inverted images on stryker endoscopy's endoscopic camera systems and devices.
Event or Problem Description
It was reported that there was inverted image.
Event or Problem Description
It was reported that there was inverted image.
Additional Manufacturer Narrative
Updating reportability awareness date based on fda acknowledgement of stryker endoscopy's decision to cease reporting for inverted images on endoscopic camera systems and devices.
Additional Manufacturer Narrative
Alleged failure: screen error message (no prior repairs, but outsourced repair malfunction message keeps appearing.) the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: no problem found.The root cause is the camera head serial number (b)(6) sent along with the coupler.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 inverted image.

• Brand Name: PKG 1788 4K COUPLER C-MOUNT
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21493558
• Report Number: 0002936485-2025-00154
• Device Sequence Number: 12867675
• Product Code: GCJ
• UDI-Device Identifier: 07613327580051
• UDI-Public: 07613327580051
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K230605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 1788210105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 04/22/2025; 05/07/2025; 04/08/2026
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/21/2025; 05/29/2025; 05/29/2025; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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