MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS FLEXIS; BOOM

Catalog Number 0682100000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the staff was allegedly injured as a result of the equipment boom not articulating up/down.After further investigation, it was reported that the user attempted to manually reposition the boom vertically, allegedly resulting in two pulled muscles.Additional information on the reported pulled muscles was requested and not yet received.The customer removed the boom from service.A stryker field service technician went onsite to replace the motor and return the unit to full use.The stryker flexis operating manual (p13742 rev.R) outlines in section 9.1.2 adjusting vertical position ¿ ¿to adjust the height of an articulating boom, press and hold the up button to raise the flexis system, press the down button to lower it, and release the button to stop movement.¿ attempting to move the boom without the buttons functioning would be considered use error.There was no reported patient involvement.

Event Description

It was reported that the staff was allegedly injured as a result of the equipment boom not articulating up/down.As this occurred prior to a case, there was no patient involvement.

• Brand Name: FLEXIS
• Type of Device: BOOM
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer Contact: adam gorzeman ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 6312886
• MDR Text Key: 66861685
• Report Number: 0002031963-2017-00002
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0682100000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2017
• 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
• Patient Outcome(s): Other