MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STANDARD CART (AUSTRALIA); CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Catalog Number 0240099011I

Device Problems No Display/Image (1183); Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that image was lost for 2 minutes during procedure.Please note that the procedure was completed successfully.

Event Description

It was reported that image was lost for 2 minutes during procedure.Please note that the procedure was completed successfully.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: "customer reported that when the door on the endo cart was closed it turned and hit the on/off switch and turned off power to the cart.".Probable root cause: the reported failure was caused by damage to the cart door.The damage may have occurred during shipping, installation or use of the product.The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.

• Brand Name: PKG, STANDARD CART (AUSTRALIA)
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10857335
• MDR Text Key: 217992058
• Report Number: 0002936485-2020-00474
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0240099011I
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1