MAUDE Adverse Event Report: PENTAX OF AMERICA, INC. VIDEO GASTROSCOPE; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number EG-2990

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Event Description

Patient was having an egd.During the egd the physician stated that he felt like biopsy forceps was difficult to pass down the biopsy channel.After biopsy was obtained the doctor complained that the scope was no longer able to hold air, and a black piece of rubber was seen in the patient's stomach.The piece of rubber was retrieved and was intact, removed with ease from the patient's stomach using a biopsy forceps.No harm was done to the patient.Scoped was pulled out and checked and found to have a large inner channel leak and was sent to the biomed department to prepare to be sent for repair.The physician was satisfied that all rubber from the inside of the scope was removed intact from the patient's stomach.

• Brand Name: VIDEO GASTROSCOPE
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): PENTAX OF AMERICA, INC.; 3 paragon drive; montvale NJ 07645
• MDR Report Key: 7027533
• MDR Text Key: 91901377
• Report Number: 7027533
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2017,11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EG-2990
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.