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

Model Number TJF-260V

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.During physical evaluation/inspection of the scope, olympus confirmed there was a gap in the adhesive at the distal end of the scope, and the wires that control the forceps elevator were raised due to be cut/frayed.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during maintenance of an evis lucera duodenovideoscope, the forceps elevator was damaged.During physical evaluation/inspection of the scope, olympus confirmed there was a gap in the adhesive at the distal end of the scope, and the wires that control the forceps elevator were raised due to be cut/frayed.There was no patient impact related to this experience.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.This event may have occurred due to physical stress which was applied to the distal end, causing the lens to break; dirt would then enter the device from the broken point, or moisture may have entered, causing corrosion of inner components.Further, the forceps elevator (identified as "k-wire") was speculated to have been raised and frayed due to repeated operation of the forceps elevator - the wire was then assumed to have broken, and thereafter, the broken wire received additional stress by brushing around the forceps elevator in manual cleaning or physical stress from non-olympus approved automatic endoscope reprocessing (aer), which caused the strands to raise.These suggested events are thought to be detectable for the following statement of the instructions for use (ifu) (operation manual): ¿important information ¿ please read before use: warnings and cautions: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ ¿3.2 inspection of the endoscope: inspection of the forceps elevator mechanism: inspection for smooth operation: visually confirm that the portion of the elevator wire extending from the distal end of the endoscope is not broken, frayed, or bent (see figure 3.5).If any damage (broken, frayed, or bent portion) is observed on the elevator wire as shown in figure 3.5, do not use the endoscope.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13256380
• MDR Text Key: 293612280
• Report Number: 8010047-2022-01423
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1