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

Model Number TJF-160VR

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

This device is not sold in the us but a similar device is.The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the forceps elevator wire was frayed, though not broken.User¿s complaint of damage was confirmed.In addition, it was noted that the connecting tube had buckles, the universal cord had buckles, the bending angle was under the specified value for the device, and the white gluing was deteriorated.Air leak inspection did not show any water leakages.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The device was returned for repair by the customer for the issue of damage to the forceps wire at the distal end.There is no reported harm to any patient.Upon evaluation of the device, it was observed that the forceps elevator wire was frayed, though not broken.This medwatch is being submitted for the reportable issue of the frayed forceps elevator wire observed during device evaluation.

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.This product was sold in september 2016 and has previously been returned for repair.Based on the results of the legal manufacturer's investigation, a definitive root cause could not be identified.However, it was surmised that this event occurred in the following mechanism: i) fatigue accumulated on k-wire by repeated operation of the forceps elevator.Then, the k-wire got snapped.Ii) the user kept using the subject device with the snapped but non-raising k-wire strand (following unsnapped strand) because they did not detect it.Iii) thereafter, the snapped k-wire was caught in the distal cover when the user attached the cover to device.Or, the snapped k-wire was contacted by the cleaning brush during the brushing process on the distal end.In this way, the snapped k-wire got frayed.The replacement of the white ring, the connecting tube, and the universal cord are required as a major repair to return the instrument to specification.The instruction manual identifies the following related verbiage: ¿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 EXERA 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: 12990343
• MDR Text Key: 283335746
• Report Number: 8010047-2021-16038
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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