MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS LIGHT HEAD VISUM 300; AC-POWERED MEDICAL EXAMINATION LIGHT

Catalog Number 0682000620

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the customer requested a m3 screw for a visum 300 light.After further investigation it was determined that a complete hardware set was required.The account was informed that the visum 300 light is nonconforming and should not be used until the repair is completed.There was no patient involvement, injury or adverse consequence reported.

Event Description

It was reported that the customer requested a m3 screw for their light.There was no patient involvement, injury or adverse consequence reported.

• Brand Name: LIGHT HEAD VISUM 300
• Type of Device: AC-POWERED MEDICAL EXAMINATION LIGHT
• 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: 6414785
• MDR Text Key: 70312539
• Report Number: 0002031963-2017-00004
• Device Sequence Number: 1
• Product Code: KZF
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0682000620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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