MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SURGISTOOL; CHAIR, ADJUSTABLE, MECHANICAL

Catalog Number	0830000000
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user was unable to lock the chair from moving.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.The device is currently pending evaluation and the model and serial number have not yet been provided.
Additional Manufacturer Narrative
The device was evaluated and the serial number was updated.Section h codes have been updated.
Event or Problem Description
It was reported that the user was unable to lock the chair from moving.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: SURGISTOOL
• Common Device Name: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 20385965
• Report Number: 0001831750-2024-01077
• Device Sequence Number: 6651953
• Product Code: INN
• UDI-Device Identifier: 07613327282566
• UDI-Public: (01)07613327282566
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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 Catalogue Number: 0830000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2004
• 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