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

Model Number TJF-Q180V

Device Problems Break (1069); Crack (1135); Material Frayed (1262); Material Separation (1562)

Patient Problems Perforation (2001); Injury (2348)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight:the patient's weight was reported as (b)(6).The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.This event has been reported by the importer on mdr# 2951238-2020-00486.

Event Description

It was reported that during a endoscopic retrograde cholangiopancreatography (ercp) while attempting a wire exchange, the elevator was not holding the wire properly.Subsequently, the cable reportedly snapped, the wire pushed through the liver causing a bile leak.As a result, the patient was admitted to the hospital.It was noted the procedure was completed with another model tjf-q180v.The patient is currently at home on hospice care.The device was inspected per usual, no anomalies.Patient treatment included hospitalization, imaging, blood transfusion and antibiotics.Per the physician, there was no allegation the patient's final condition is a result of the device or procedure, only the hospitalization was unexpected.

Manufacturer Narrative

This report is being supplemented to provide additional information (d11) and corrected data (d10) regarding the reported event.

Manufacturer Narrative

This report is being updated to report the investigation results.New information is reported in h4, h6 , h10.Physical evaluation of the returned complaint device reveals: c cover: a trace of pressing, scratch, bonding part of the a rubber: crack, objective lens: chipping, bending section: the a-braid was frayed, insertion tube: scratch, wrinkle, and k-wire: broken stopper pin.The repair history for the complaint device was evaluated.In the history,repairs which might have influenced on durability of k-wire were following two repairs.Repair of may 31, 2019, k-wire replacement.Repair of february 2020, major repair of this repair-mentioned repair, following description was included.We presumed that k-wire was not replaced.(k-lever forceps elevator, non-critical).The adverse event of the reported was perforation of the bile duct by a non-olympus guidewire.The adverse event was reported that it was caused by insufficient fixation of the guidewire by the forceps elevator of the subject device when replacing the guidewire during patient procedure.Device history record review confirmed that the subject device was manufactured and shipped in accordance with specifications.The guidewire was found to be a boston scientific¿s guidewire.However, the guidewire was not sent to olympus.Olympus obtained a jagwire, compatibility of which with endoscopes was confirmed, having 0.91 mm of the maximum outer diameter and confirmed as follows; the inspected product was a single-use product.At the tip of the guide wire, a 50 mm soft-resin-made distal chip was equipped.The soft -resin-made distal chip was designed to not easily penetrate the bile duct.It was difficult to identify occurrence mechanism of the adverse event because the used guidewire nor a case of perforation of the bile duct caused by failure of the forceps elevator were able to be confirmed.

• Brand Name: EVIS EXERA II 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: 10419611
• MDR Text Key: 203305984
• Report Number: 8010047-2020-05569
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 66