MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS SPRING ARM, LIGHT 12-18KG; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number 0682000112

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that there was a flashing service light and a surgical light that would not turn on for the visum halogen lights suspension.A stryker field service technician (sfst) was dispatched to investigate, and during his troubleshooting, he noted the m3 safety screw missing from the light 1 spring arm collar of the spring arm.The spring arm was replaced, and it was verified that the replacement spring arm had the m3 safety screw installed.During his visit the sfst spoke with the biomed at the account, but the biomed was unaware as to how the m3 safety screw went missing.A review of the service history was conducted, and there are no previous service records found for the affected spring arm and light head.Although the exact root cause of this issue is unknown, the most likely root cause would be improper preventative maintenance and service by hospital personnel.There was no patient involvement, injury or adverse consequence reported.

Event Description

It was reported that there was a flashing service light and a surgical light that would not turn on for the visum halogen lights suspension.A stryker field service technician (sfst) was dispatched to investigate, and during his troubleshooting, he noted the m3 safety screw missing from the light 1 spring arm collar of the spring arm.There was no patient involvement, injury or adverse consequence reported.

• Brand Name: SPRING ARM, LIGHT 12-18KG
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: jenny harris ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 7562681
• MDR Text Key: 109897370
• Report Number: 0002031963-2018-00005
• Device Sequence Number: 1
• Product Code: FSY
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0682000112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• 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