MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS NEW TELETOM; TABLE, OPERATING-ROOM, AC-POWERED

Catalog Number GEN00000001

Device Problem Device Handling Problem (3265)

Patient Problem Abrasion (1689)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

It was reported during an acl surgical case the physician asked for the or table to be elevated with a patient on the or table.The or table was articulated up, and the patient's arm got caught under the teletom boom.When or staff attempted to move the boom, the boom would not articulate.The or staff had to lower the table to move the patient's arm.This caused an abrasion on the arm.Post op x-rays were performed to confirm there were no fractures to the arm.There were no reported injuries.The customer was able to confirm that the surgical table used was a skytron table, 3501b ez slide, s/n (b)(4).  a stryker field service technician (sfst) reached out to the customer and confirmed that the boom was not articulating.  the sfst asked the customer to check the emergency motor shut-off button on the boom and confirmed that it was pressed inward.If the stop button is pushed inward it turns off power to the boom motor and prevents the boom from articulating.The customer contact pulled out the emergency motor shut-off button and confirmed that the boom was able to articulate up/down with no further issues.There was no reported malfunction of a stryker device.The field service investigation can be referenced on salesforce case# (b)(4).  based on the information reported, the most likely root cause would be attributed to user error.It is possible at some point the emergency motor shut-off button was pushed inward purposefully to prevent boom movement during the procedure or on accident by an end-user while cleaning/wiping down the surface or bumped by another device in the operating room.Medical intervention (i.E.X-ray) was required to determine if a serious injury had occurred.The x-ray(s) confirmed no injury.There was no reported malfunction of a stryker device and no reported injuries.If any further information is obtained around this event, a supplemental will be filed.

Event Description

It was reported during a procedure the physician asked for the or table to be elevated with patient on the or table.The or table was articulated up and then the patient's arm got caught under the teletom boom.When or staff attempted to move the boom, the boom would not articulate.The or staff had to lower the table in order to move the patient's arm.This caused an abrasion on the arm.Post op x-rays were performed to confirm there were no fractures to the patient.There were no reported injuries or adverse consequences.

• Brand Name: NEW TELETOM
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 12929071
• MDR Text Key: 286767194
• Report Number: 0002031963-2021-00017
• 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: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: GEN00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2021
• 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