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

Catalog Number 0240099158

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

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 arm of cart was drifting.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Identified problem: ¿our customer at bozeman deaconess recently purchased some new connected or carts (sn (b)(6)), and we are having issues with one of the carts not being able to hold tension on the monitor arm for tilting the screen.¿ evaluation: our evaluation included testing the tilter using the stryker sv7 monitor.The monitor was attached to the tilter and placed in three different positions: middle, top, and bottom.The tilter held its position in the middle and top position.Moving the monitor from top to bottom, the monitor dropped to the lowest position without any internal resistance from the tilter.Repeating this cycle (top to bottom) several times produced similar outcomes.A review of the tilter found that it had the number ¿20¿ stamped into the tilter (see tilter picture).The supplier changed the internal coating for the tilter from oxidized to zinc coating as a design improvement at some point in 2020.Conclusion: the tilter appears faulty because it will not hold its position.We will return the tilter to the manufacturer for further evaluation.2 supplier evaluation: on february 16, 2022, the supplier provided their evaluation.The supplier assumed the failure mode for this tilter was similar to fb #80, in which the ¿hardness of the tilter rivet was above specification.The high hardness prevented the rivet from being properly deformed, which resulted in the tilter having a low torque value.¿ so with the current tilter (fb #84), supplier evaluation concluded that ¿the breakaway torque and the rivet hardness was within spec.The tilter had to be disassembled to measure the rivet hardness so further analysis cannot be performed.¿ the supplier also confirmed that ¿the shaft had a black zinc coating as would be expected with the date code of 2020 on the tilter body.There was some wear of the black zinc.¿ see the picture below.Conclusion: our internal evaluation found that the tilter was faulty because it will not hold its position and returned it to the supplier for further investigation.They confirmed that the tilter failure was not a result of the incorrect rivet harness.Still, since they had to disassemble the tilter, they could not determine other potential failure modes.We are closing this complaint with no further action.The device manufacture date is not known.The reported failure mode will be monitored for future re occurrence.

Event Description

It was reported that the arm of cart was drifting.

• 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: 12969356
• MDR Text Key: 283586010
• Report Number: 0002936485-2021-00699
• 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: 03/08/2022

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: Health Professional
• Device Catalogue Number: 0240099158
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 03/08/2022
• 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