MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SURGISTOOL; STRETCHER, WHEELED

Catalog Number 0830000000

Device Problem Unstable (1667)

Patient Problems Fall (1848); No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; 1 device had a bent component and the other device had missing components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 2 malfunction events, where it was reported the device wouldn't hold weight.There was one instance of patient involvement where the patient fell but was not injured.

• Brand Name: SURGISTOOL
• Type of Device: STRETCHER, WHEELED
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 9633931
• MDR Text Key: 176501278
• Report Number: 0001831750-2020-00106
• 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: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0830000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/01/2020
• 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