MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DUODENOVIDEOSCOPE

Model Number TJF-150

Device Problems Contamination (1120); Material Twisted/Bent (2981); Failure to Clean Adequately (4048)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device is returned, and an evaluation completed for it.Upon inspection and testing, it was observed that the forceps elevator has presence of foreign material.Also, the control unit is dirty.This is attributed to insufficient cleaning.In addition, the light guide (lg) lens has dirt on the inside.This is caused by physical or chemical stress.The forceps elevator wire (k-wire) was damaged with a bent part.This is likely caused by mechanical/chemical stress applied by repeated use for the long duration.Due to cut on k-wire, forceps raising angle does not meet the standard value.Other observation for the device: adhesive on distal end rubber coating (a-rubber) is detached; a-rubber is slack; connecting tube has coating peeling and buckling; due to wear of angle wire, bending angle in all directions does not meet the standard value; due to wear of angle wire, the play of up/down and right/left knob is out of the standard value; universal cord has a dent; distal end cover (c-cover) has a dent; adhesive around lg lens has wear; connecting tube and control unit have a scratch.The user¿s complaint of broken forceps elevator wire was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The customer returned the device for evaluation and repair for the issue of the forceps elevator wire being broken at the end of an unknown procedure.There is no reported harm to the patient.Upon evaluation of the returned device, it was observed that the forceps elevator has presence of foreign material.Also, the control unit is dirty.This is attributed to insufficient cleaning.In addition, the light guide (lg) lens has dirt on the inside.This is caused by physical or chemical stress.The forceps elevator wire (k-wire) was damaged with a bent part.This is likely caused by mechanical/chemical stress applied by repeated use for the long duration.This medwatch is being submitted for the reportable issue of presence of foreign material on the forceps elevator, dirt on control unit, dirt inside the lg lens, and bent part of the k-wire as observed during device evaluation.

Manufacturer Narrative

There is more information on the device evaluation.Additional information has also been received from the customer.This supplemental report is being submitted to provide this information.No patient details, including pre-existing medical conditions, will be provided.Model and serial numbers of the devices used in conjunction with the device at the time of the event are unknown.Customer is trained on reprocessing as per instructions for use (ifu) by olympus field service and is correctly performing the reprocessing steps without doing any delay of precleaning.Since the forceps elevator wire was cut, the reprocessing could not be performed completely; reprocessing or brushing elevator could not be performed by the customer.The device was returned with completing the reprocessing.It is not likely that the device with the presence of foreign material was used in another patient, as the device had no issues in the inspection prior to use, and the device was sent for repair with the issue found at the end of the procedure.Reprocessing could not be done by the customer during return and thus foreign material was found in workshop inspection.Customer does not have an automatic endoscopy reprocessor.Reprocessing is performed manually.Brushes used by customer for tjf-150 are: maj-1534, mh-507, and bw-20t.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.There is no repair history on the subject device.Foreign material and dirt in the device could not be identified.Nonconformities of the subject device were confirmed from device evaluation.However, it the influence of nonconformity to the suggested event could not be judged.Root cause for the cut off forceps elevator wire (k-wire) with bent part, dirty control unit, and foreign material found in the forceps elevator and light guide lens cannot be conclusively determined.However it is likely that the k-wire strands were cut off and raised up due to repeated manipulation of forceps elevator.·k-wire strands were cut off and raised up due to breakage of k-wire by chemical stress.Regarding the cause of foreign material remained in the device and dirty control section, since complete and proper reprocessing steps recommended in ifu could not be performed completely due to device nonconformity, it caused the foreign material at/around the forceps elevator to remain in the device.Regarding foreign material in the light guide (lg) lens: - since the material was not at external surface of the device, the material could not be removed by reprocessing.It is likely the lens glue was peeled off due to physical stress by hitting/dropping distal end, chemical stress by chemical solutions, etc.As a result, humidity invaded lg lens which led to corrosion.Suggested event: control section was dirty the ifu includes the following statements: ifu (reprocessing manual) states if cleaning, disinfect, and sterilization of endoscope was insufficient, the device may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.All channels of the endoscope, including the elevator wire channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.

Event Description

Addendum mar 4, 2023: the procedure was therapeutic endoscopic retrograde cholangiopancreatography (ercp) stenting.There was no issue with the device in the inspection prior to use.The procedure was completed with the same device without any delay.The patient did not need to be given additional anesthesia.

• Brand Name: DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16059649
• MDR Text Key: 308485988
• Report Number: 9610595-2022-06170
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K954451
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2011
• 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