MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS CHROMOPHARE; SURGICAL LIGHT, CEILING MOUNTED

Catalog Number CH00000001

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the light had no control.A stryker field service technician (sfst) was dispatched for investigation.During investigation the sfst noticed there was a gap between the top arm and bottom arm was large.The sfst removed the endo light from the suspension and saw that spanner nut and snap ring was missing from the suspension assembly.The spanner nut and snap ring missing was allowing the suspension arm to separate.Without this spanner nut and/or snap ring at the bottom of the suspension assembly the lower suspension arm began to disengage from the central shaft.The sfst repaired the unit and returned it to service.There was no injury or adverse consequence to the patient/user.

Event Description

It was reported that the light had no control.There was no injury or adverse consequence to the patient/user.

• Brand Name: CHROMOPHARE
• Type of Device: SURGICAL LIGHT, 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: adam gorzeman ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 6817984
• MDR Text Key: 83538769
• Report Number: 0002031963-2017-00009
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2017
• 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