MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number TJF-Q190V

Device Problems Positioning Failure (1158); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) of Esophagus (2398)

Event Date 04/24/2021

Event Type  Injury  

Event Description

It is reporting during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope, an unspecified boston scientific device was sent down the working channel of the duodenoscope and got stuck.The physician removed the scope with the device still stuck and protruding out the distal end (presumably with the elevator not in the proper position since it was stuck).At the time, the physician did not notice anything abnormal with the patient.Later it was discovered there was a tear at the distal end of the esophagus.The physician did rectify this to stop the bleeding (it is unstated how).The patient stayed overnight in the icu.The patient's current condition as of today is "doing fine." the physician is not certain what caused the tear.Additional details regarding the patient and event have been requested with no response to date.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11832267
• MDR Text Key: 251116196
• Report Number: 2951238-2021-00338
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/24/2021,05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1