MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number MAJ-2315

Device Problems Burst Container or Vessel (1074); Stretched (1601); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Patient underwent ercp using a new disposable cover duodenoscope.During the procedure while using the balloon, the balloon popped.This was an unusual occurrence.A second balloon was inserted and it was noticed that it was stretching and not performing properly.It was removed just before it also popped.A stent was then passed through the scope and the it was noticed that the elevator was very resistant but the stent was able to be successfully deployed.Upon removing the duodenoscope from the patient, it was immediately noticed that the disposable duodenoscope cover was split in half.Behind the cover was a number of stone-like material lodged in the distal tip.This was thought to be the likely reason the elevator channel was so resistant.Of note, under normal circumstances, the duodenoscope cover remains intact and at the end of the case, it is required to crack the cover to get it off the scope, so splitting of the cover is expected but it should not occur while in the patient.There weren't any procedural or anatomical difficulties that were known to have contributed to the distal cover splitting.Once the duodenoscope was cleaned, the scope was found to be in working order and the elevator was moving without issue and therefore was not returned to olympus.The procedure was completed without any adverse effects to the patient as a result of the difficulties experienced during the procedure.The patient was discharged home in stable condition.After this event with the duodenoscope, the physician requested that we bring back our old duodenoscopes.Manufacturer response for endoscope, accessories, narrow band spectrum, single use distal cover (per site reporter).The olympus rep provided a duodenoscope cover application inservice to the gi technicians.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 15248509
• MDR Text Key: 298149116
• Report Number: 15248509
• Device Sequence Number: 1
• Product Code: NWB
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Catalogue Number: MAJ-2315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White