MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number HX-400U-30

Device Problem Application Program Problem (2880)

Patient Problem No Information (3190)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

Utilizing the polyloop during a colonoscopy, the loop would not release properly.Had to cut off the handle to remove the scope.Inserted another scope with utilizing many items to retrieve or release the loop.Removed entire polyloop with a portion of the polyp that was retrieved.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 6621337
• MDR Text Key: 76968090
• Report Number: 6621337
• Device Sequence Number: 1
• Product Code: FDT
• 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: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Model Number: HX-400U-30
• Device Lot Number: 68V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ONLY THE GI COLONOSCOPE WAS IN USE BUT DID NOT CON
• Patient Age: 79 YR
• Patient Weight: 65