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

Catalog Number 0240099158

Device Problems Mechanical Problem (1384); Device Slipped (1584)

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

Event Date 11/30/2022

Event Type  malfunction  

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 cart arm was drifting.

Event Description

It was reported that the cart arm was drifting.

Manufacturer Narrative

The product was returned to the supplier for investigation and the reported failure mode was confirmed.Identified problem: "not holding tension.¿ tekna investigation results: "hd-articulating arm, confirmed that arm would not stay in upright position, even when counter balance tension was adjusted to maximum balance serial number obtained from the arm is (b)(6).Conclusion possible gas cylinder failure.Disposition: unit will be sent back to human active technology (hat) for evaluation" the reported failure mode will be monitored for future re occurrence.Manufacture date is not known.

• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15988665
• MDR Text Key: 306175865
• Report Number: 0002936485-2022-00754
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 02/14/2023
• 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