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

Catalog Number 0682000112

Device Problems Installation-Related Problem (2965); Misassembly During Maintenance/Repair (4054)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported on (b)(6) 2019 in or 2, the visum halogen surgical light fell during a case.There were no reports of any injury or adverse event.A stryker field service technician (sfst) was dispatched.During his investigation he discovered that the spring arm disengaged while the hospital staff was reportedly positioning the light.The sfst noted that there was substantial amount of grease and debris around the area where the circlip seats, which secures the spring arm to the horizontal arm of the suspension.The service history found that on 01sep2019 a sfst was dispatched to address the light not turning on in operating room 2.It was determined that a new spring arm was needed to complete the repair.The sfst replaced the spring arm noting that the spring arm circlip was checked with his go-no go gauge during the installation process, functional testing was performed, and equipment was placed back into service and the issue was reportedly resolved.The equipment was returned for investigation.Potential reasons for the failure could include the cclip being out of position due to the small damage on the spring arm and/or due to misidentification of passing the go-no go gauge during the installation process.

Event Description

It was reported that the in or 2 the light fixture fell from the ceiling during a case.There were no reports of any injury or adverse event.

• 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: kimberly lynch ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 9134057
• MDR Text Key: 218745844
• Report Number: 0002031963-2019-00004
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0682000112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/30/2019
• 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