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 Patient Involvement (2645)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported on (b)(6) 2019 in operating room 2, the visum halogen surgical spring arm disengaged while the stryker field service technician (sfst) was providing service for salesforce complaint case (b)(4).There were no reports of any injury or adverse event.The sfst installed a new spring arm noting the spring arm circlip, which secures the spring arm to the horizontal arm of the suspension, was checked with his go-no go gage.The sfst performed functional testing by adding excessive loading on the spring arm.The spring arm disengaged from the suspension and was taken out of service.On 17sep2019 a sfst was dispatched and installed a new spring arm with a new circlip and verified the circlip was properly seated with his go-no go gage.The equipment was returned for investigation.Potential reasons for the failure include the cclip not being properly seated due to excessive loading placed on the spring arm and/or due to misidentification of passing the go-no go gage during the installation process.

Event Description

It was reported on (b)(6) 2019 in or 2, the visum halogen surgical spring arm disengaged while the stryker field service technician (sfst) was providing service for salesforce complaint case (b)(4).

• 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: 9134061
• MDR Text Key: 218746417
• Report Number: 0002031963-2019-00003
• 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: 09/09/2019
• 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