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

Catalog Number 0240099158

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the arm of cart was drifting.

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.

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 Description

It was reported that the arm of cart was drifting.

Event Description

It was reported that the arm of cart was drifting.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: "it was reported by the sales rep michael duvert arm spring has lost its tension.Wont adjust.Dropped to the bottom" probable root cause: probable root cause cannot be determined as final approval of investigation results by oem tekna is still pending as of 19 apr 2022.Interim findings from tekna are as follows: "we returned this arm to our supplier for evaluation.The strut inside completely failed, losing all pressure.They have sent it to the strut manufacturer for evaluation.I will let you know when i have more information." the device manufacture date is not known.The failure mode will be monitored for future reoccurrence.

• Brand Name: CONNECTED OR MOUNT
• Type of Device: 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: 13213768
• MDR Text Key: 285735685
• Report Number: 0002936485-2022-00021
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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
• Device Operator: Other
• Device Catalogue Number: 0240099158
• Device Lot Number: 2020-0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1