MAUDE Adverse Event Report: MAQUET S.A.S. ORCHIDE

Model Number OHD SET

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

The hosp reported that a camera broke and detached from the light head while being manipulated by a doctor.The camera remained attached to the light head, suspended by its cables.No injuries nor adverse effects were reported.(b)(4).

Manufacturer Narrative

A maquet field service tech (fst) evaluated the device.He found evidence this device collided with other objects in the operating room.Repeated impacts of the device are capable of dislodging the camera.The fst replaced the camera with a new one.The orchide camera yearly maintenance program includes a verification of the condition of the plastic covers and absence of scratches.Maquet med systems usa submits this report on behalf of the device mfg facility.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: ORCHIDE
• Manufacturer (Section D): MAQUET S.A.S.; orleans ; FR
• Manufacturer (Section G): MAQUET S.A.S; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3987468
• MDR Text Key: 4885979
• Report Number: 9710055-2014-00043
• Device Sequence Number: 1
• Product Code: KQM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014,05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OHD SET
• Device Catalogue Number: 567702910C
• Other Device ID Number: 567702904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2009
• 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