MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS EXTENSION ARM, ACROBAT 2000, 750MM; SURGICAL LIGHT

Catalog Number 0682001489

Device Problems Difficult To Position (1467); Difficult to Advance (2920)

Patient Problems No Patient Involvement (2645); Muscle/Tendon Damage (4532)

Event Date 08/05/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the end user allegedly injured their shoulder while attempting to move the flat panel monitor.A stryker field service technician (sfst) was dispatched for investigation.While onsite the sfst visually inspected the horizontal arm, as well as inspected the movement of the system, and found the horizontal arm stiff/difficult to move on the flat panel spring arm.The stryker flat panel & navigation arm system operations and maintenance manual, in section 11.1, inspection schedule, lists "movement of system" as an inspection responsibility for hospital personnel every 6 months.Section 11.3, adjusting the movement of the system, states "if during product inspection the system has become noticeably more difficult to maneuver, check the friction brakes to see if they are over-tightened.If after readjusting the friction brakes, the system remains stiff please notify stryker technical support or your stryker representative so that preventative maintenance can be performed in the form of greasing all stiff joints." the reported injury occurred on (b)(6) 2016 but was reported to stryker on 5-aug-2016.There was no patient involvement.In addition, no malfunction of the flat panel occurred and this instance was reported to have occurred outside of a procedure.

Event Description

It was reported that the end user allegedly injured their shoulder while attempting to move the fp monitor.There was no patient involvement reported with the complaint.

Manufacturer Narrative

There has been corrected data updates made to the following fields: outcomes attributed to ae, reporting contact, clinical signs code grid, health impact code grid, conclusion code grid, device code grid, method code grid, and component code grid.

Event Description

It was reported that the end user allegedly injured their shoulder while attempting to move the fp monitor.There was no patient involvement reported with the complaint.

• Brand Name: EXTENSION ARM, ACROBAT 2000, 750MM
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• MDR Report Key: 5918356
• MDR Text Key: 53614685
• Report Number: 0002031963-2016-00014
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: 0682001489
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: 08/05/2016
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other