MAUDE Adverse Event Report: PENTAX MEDICAL (PENANG) SDN. BHD GASTROSCOPE; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problems No Display/Image (1183); Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2021

Event Type  malfunction  

Event Description

When hooking up the gastroscope to the tv, nothing came on.Also, no suction was noted.The cord was switched out and still no video.A new gastroscope was obtained and video worked.

• Brand Name: GASTROSCOPE
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): PENTAX MEDICAL (PENANG) SDN. BHD; 3 paragon drive; montvale NJ 07645
• MDR Report Key: 12638575
• MDR Text Key: 276588552
• Report Number: 12638575
• Device Sequence Number: 1
• Product Code: FDS
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 136