MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CONNECTED OR CART, 120 V; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Model Number	240099155
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device lost image during a case.There was a 15 minute delay while replacing the device.There is no report of adverse consequences as a result.
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 product was returned to the supplier for investigation and the reported failure mode was confirmed.Alleged failure: black component strain relief broken pulling on power cord.Evaluation: "mfg process ensures cord slack between power cord panel/strain relief bushing and corc to prevent power cord from becoming unplugged from corc during normal use.Power cord panel on returned cord is bent indicating power cord was pulled with excessive force.Unit may have been moved (towed) by power cord instead of handles.The power cord was then pulled through the power cord panel.Cord slack was overcome which unplugged the main power input into the connected or cart.This excessive force caused the strain relief bushing to fail in its engagement to the power cord panel." probable root cause as per manufacturer investigation: "this excessive force caused the strain relief bushing to fail in its engagement to the power cord panel." the reported failure mode will be monitored for future re occurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the device lost image during a case.There was a 15 minute delay while replacing the device.There is no report of adverse consequences as a result.

• Brand Name: CONNECTED OR CART, 120 V
• Common Device Name: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15095250
• Report Number: 0002936485-2022-00428
• Device Sequence Number: 14812012
• Product Code: BZN
• UDI-Device Identifier: 00858701006360
• UDI-Public: 00858701006360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/06/2022

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: 240099155
• Device Catalogue Number: 0240099155
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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