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

Model Number TJF-160R

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing of the returned device, the damaged forceps elevator wire was found to be due to mechanical/chemical stress.In addition, service found that the adhesive on the bending section cover had a gap, the bending section cover was discolored, the connecting tube was scratched and wrinkled, the grip was scratched, the indication on the grip was unclear, the scope connector cover was discolored, the scope connector was dented, the suction cylinder was discolored, switch button #1 was scratched and would not work, the color ring was cracked, the switch box was scratched, the protector of the universal cord on the scope connector side was scratched, the universal cord was scratched and deformed, the bending angle in the right/left direction was out of specification due to wear of the angulation wire, the suction volume was out of specification, the light guide lens was chipped, scratched, and discolored, and the connecting tube was discolored.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that during reprocessing of the subject device, one thread in the forceps elevator wire was found to be broken.There was no patient or user injury due to the event.The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed that the forceps elevator wire was broken and bent.This report is being submitted for the malfunction found during evaluation (the forceps elevator wire was broken and bent).Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

Correction to the initial medwatch.The aware date should be 24-feb-2022.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 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon of the wire being cut with a bent part was presumed to have been due to fatigue/breakdown due to repeated operation of the forceps elevator.Moreover, the wire was frayed and raised by repeated brushing around the forceps elevator and attachment/ detachment of the distal cover.Users can detect the suggested event properly by handling the device in accordance with the following instructions for use (ifu): "the elevator wire at the distal end is damaged (broken, frayed, or bent), the damaged elevator wire may cause injury or pose an infection control risk when detaching of the distal cover or cleaning the endoscope.In this case, carefully detach the distal cover and perform cleaning.Preparation and inspection: attaching the distal cover: when attaching the distal cover, make sure to confirm that the portion of the elevator wire at the distal end is not broken, frayed, or bent.Otherwise, the broken elevator wire may cause injury.Also, if the broken elevator wire is deformed, it may compromise patient, operator, or other medical personnel safety." users can reduce/prevent the suggested event by handling the device in accordance with the following ifu: "cleaning, disinfection and sterilization procedures: brushing around the forceps elevator and instrument channel outlet: using a stiff brush or excessive force when brushing may scratch the distal end and result in water leakage; cause the elevator wire to come off the distal end, bend or kink the elevator wire so that the forceps elevator will no longer work.Preparation and inspection: attaching the distal cover" 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: 13971782
• MDR Text Key: 298132153
• Report Number: 8010047-2022-05494
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K980465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

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: TJF-160R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 05/23/2022; 09/01/2022
• Supplement Dates FDA Received: 06/17/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2005
• 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