MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS PKG, SWITCHPOINT INFINITY 3 LITE; SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL

Catalog Number	0678003000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the endo cam image would not display after patient had been placed under anesthesia.Endo cam fault happened prior to surgery and could not be resolved.Patient had to be woke up from anesthesia and surgery re-scheduled.There were no reported injuries.
Event or Problem Description
It was reported that the endo cam image would not display after patient had been placed under anesthesia.Endo cam fault happened prior to surgery and could not be resolved.Patient had to be woke up from anesthesia and surgery re-scheduled.There were no reported injuries.
Additional Manufacturer Narrative
On (b)(6) 2024, it was reported that part number 0678003000 (pkg, switchpoint infinity 3 lite) was involved in the following event.It was called in stating that they are unable to get a video signal when routing endocam.Procedure was cancelled.Endo cam image would not display after patient had been placed under anesthesia.Endo cam fault happened prior to surgery and could not be resolved.Patient had to be woke up from anesthesia and surgery re-scheduled.On (b)(6) 2024, a stryker field service technician went onsite to investigate the device.It was determined that the tx dvi broadata was faulty and needed to be replaced.The issue was resolved by replacing broaddata extender.The fst disconnected the fibers and dvi cable from the faulty broadata, then reconnected all cables to the new broadata.The resolution was verified by confirming that the endo cam image could be routed and displayed on all monitors without issues.Multiple attempts for further event details and patient status were completed but no response was received.If any further information is received, a supplemental will be filed.

• Brand Name: PKG, SWITCHPOINT INFINITY 3 LITE
• Common Device Name: SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 18898311
• Report Number: 0002031963-2024-00002
• Device Sequence Number: 15353006
• Product Code: LMD
• UDI-Device Identifier: 07613327054255
• UDI-Public: 07613327054255
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K100852
• 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): 06/04/2024

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: 0678003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2016
• 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