MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SURGISTOOL; STOOL, OPERATING-ROOM

Catalog Number 0830000000

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced drifting down slowly and fluid leaks onto floor.There was no patient involvement.

Manufacturer Narrative

It was originally reported that there the device had a fluid leak onto the floor which is not reportable.Because of this, the number of reported events has been changed from 0 to 1.This device that was also drifting will be covered under mfr # 0001831750-2023-01204.

Event Description

This report summarizes 0 malfunction event, where it was reported the device experienced drifting down slowly and fluid leaks onto floor.There was no patient involvement.

• Brand Name: SURGISTOOL
• Type of Device: STOOL, OPERATING-ROOM
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18005783
• MDR Text Key: 326524045
• Report Number: 0001831750-2023-01289
• Device Sequence Number: 1
• Product Code: FZM
• UDI-Device Identifier: 07613327282566
• UDI-Public: 07613327282566
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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
• Date Manufacturer Received: 10/01/2023
• 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