MAUDE Adverse Event Report: PENTAX OF AMERICA, INC. RADIANCE G2; CAMERA, SURGICAL AND ACCESSORIES

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2022

Event Type  malfunction  

Event Description

During colonoscopy, monitor used for physician to view went blank.Staff moved stretcher and physician able to perform case with monitor located behind her.Same monitor has failed two days prior.Biomed was on the scene and changed out the transformer, a work ordered was placed however monitor screen resumed function and no intervention was necessary.Screen down and not coming back on, image was slaved to portable screen.

• Brand Name: RADIANCE G2
• Type of Device: CAMERA, SURGICAL AND ACCESSORIES
• Manufacturer (Section D): PENTAX OF AMERICA, INC.; 3 paragon drive; montvale NJ 07645
• MDR Report Key: 13757207
• MDR Text Key: 287127216
• Report Number: 13757207
• Device Sequence Number: 1
• Product Code: KQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1