MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS TELETOM; BOOM

Catalog Number TEL00000001

Device Problem Human-Device Interface Problem (2949)

Patient Problem Injury (2348)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that nurse allegedly fractured her hand between the boom and a equipment cart when moving the boom downwards.The nurse went into the emergency room after the incident to have her hand was examined, and her knuckle around her middle finger was allegedly crushed.An x-ray was performed and it was concluded that she has a torn tendon (not fractured).The nurse is out for 2 weeks on medical leave and will have a hand specialist to look at her hand.Stryker field service technician (sfst) was dispatched to the account to investigation.During his initial visit, functional testing of the boom was performed, which included articulating the boom up and down 10 times, but the issue could not be replicated.The sfst informed the account of his findings, but they requested that the up/down switch be replaced.The sfst replaced the switch and performed functional testing.The boom passed all functional testing, and the device was placed back into service.The installation history for the teletom booms in or 11 was reviewed and it was found that the unit was installed on 11 april 2003.The service history for the boom was also reviewed, and there were no service tickets found related to issues for the up/down switch or articulation.Although the exact root cause of this issue is unknown, based on the information reported, the most likely root cause would be attributed to user error, as an equipment cart was reportedly placed directly beneath the boom at the time the incident occurred.In addition, there are height limits built within the boom that prevent the boom to keep moving downward.However, due to the placement of the cart underneath the boom it prevented the limits from engaging.

Event Description

It was reported that the nurse fractured her finger as a result of the equipment boom articulating down onto an equipment cart.

• Brand Name: TELETOM
• 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: kimberly lynch ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 9343794
• MDR Text Key: 182132085
• Report Number: 0002031963-2019-00005
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TEL00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/19/2019
• 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