MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ190

Device Problems Device Emits Odor (1425); Smoking (1585); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The evaluation found insufficient or incorrect reprocessing of the scope as evidenced by the presence of white powder clogging the channel.In addition, a chip on the plastic distal end cover, connection tubing has buckling and wrinkle,there is evidence of wear to the angle wire, debris on the top of the lg lens, and the bending section cover is detached, chipped and worn.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus an electrical smell and smoke were observed coming from the end of the scope upon removal from a patient during a procedure.Due to the problem, it was necessary for the patient to stay overnight in the hospital for observation.Additional information about patients condition has been requested but not received at the time of this report.

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The evaluation found insufficient or incorrect reprocessing of the scope as evidenced by the presence of white powder clogging the channel.In addition, a chip on the plastic distal end cover, connection tubing has buckling and wrinkle,there is evidence of wear to the angle wire, debris on the top of the lg lens, and the bending section cover is detached, chipped and worn.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus an electrical smell and smoke were observed coming from the end of the scope upon removal from a patient during a procedure.Due to the problem, it was necessary for the patient to stay overnight in the hospital for observation.Additional information about patients condition has been requested but not received at the time of this report.

Manufacturer Narrative

This supplemental report is submitted to provide additional event information and the results of the legal manufacturer¿s investigation.Updates to sections b3, b5, h4 and h6.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.Based on the available information, the investigation determined the likely cause of the reported "electrical smell and smoke were observed coming from the end of the scope upon removal from a patient" was likely due to blood or mucosa adhering to the light guide (lg) lens and absolved light; then it resulted in increase of temperature and production of smoke.After that, moisture of blood or mucosa evaporated, and blood or mucosa adhered to the lg lens.The likely cause of the white powder clogging the channel of the scope was inappropriate reprocessing, resulting in residues of detergents that dried and hardened within the air/water channel.As stated in the instructions for use: - if blood or mucosa adheres to the illumination lens to the distal end of the endoscope, and if the endoscope is continuously used while blood or mucosa is not removed and the illumination lens is discolored, temperature at the distal end of the endoscope may increase, and it may result in burn of a patient or an operator.- if the endoscope is used under the maximum intensity of light or used for a long time, smoke-like vapor may appear in an endoscope image.This phenomenon is caused by heating of and evaporation of moisture from organic materials (blood, moisture in debris) around the illumination lens.As stated in the instructions for use, as a preventive measure: · "if the endoscopic image becomes dimmer during the procedure, it may indicate that blood or mucus is adhering to the light guide lens on the distal end of the endoscope or that the light guide lens has been discolored.Immediately withdraw the endoscope from the patient, remove blood or mucus, and confirm that the light guide lens has no irregularities to use it again.If you continue to use the endoscope with its obstructed or discolored light guide lens, the temperature at the distal end may rise, which may cause patient injury or operator and/or patient burns." ·"set the brightness of the light source to the minimum level necessary to perform the procedure safely.If the endoscope is used for a prolonged period at or near maximum light intensity, vapor may be observed in the endoscopic image.This is caused by the evaporation of organic material (blood, moisture in stool, etc.) due to heat generated by the light guide near the light guide lens.If this vapor continues to interfere with the examination, remove the endoscope, wipe the distal end with lint-free cloths moistened with 70% ethyl or 70% isopropyl alcohol, reinsert the endoscope, and continue the examination." ¿ "to prevent clogging of the air/water nozzle, always use the aw channel cleaning adapter to clean the air/water channel after each use." ·"the endoscope and accessories are compatible with several methods of reprocessing.However, not all reprocessing methods are compatible with all endoscopes and all accessories.Reprocessing with incompatible methods can cause equipment damage even if the number of reprocessing cycles is small.For appropriate reprocessing methods, see table 3.1.Follow the policies at your local institution when choosing which methods listed in table 3.1 to employ.".

Event Description

The patient involved presented with a history of gastrojejunostomy and food bolus.The procedure was intended to investigate possible food bolus and dilate the anastomosis site.As reported by the user facility, the patient was admitted overnight for observation as a result of the patient's existing clinical condition.The intended procedure was a gastroscopy and a balloon dilator was used without incident during the procedure.The user facility reported that the light source changed color mid procedure and appeared red momentarily instead of white; the procedure continued without incident after this.After the scope was removed from the patient and the terminal was cleaned at the bedside, that the tip was noted to be emitting smoke and a "burning" odor was present.The processor was turned off twice and each time it was turned back on to complete the cleaning process the "smoke and smell" resumed.Once the light source was turned off, the scope could be cleaned without issue.On further investigation, the tip appeared charred.The device was operated by an experienced surgical consultant and the user did not report any difficulties with the functioning of the scope apart from the light changing color briefly.No smoke or burning was noted during the procedure.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 07-dec-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation per capa-200413.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, although foreign material was found, the specific material could not be identified.No physical damage was observed at the site where the foreign material remained.Also, it could not be confirmed whether the reprocessing method deviated from the instructions for use (ifu).Therefore, it could not be determined why the foreign material remained.The event can be detected/prevented by following the ifu which state: ¿inspection of the endoscope: inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ ¿inspection of the endoscopic system inspection of the air-feeding function inspection of the objective lens cleaning function¿.This supplemental report includes corrections to d8, d9 and h4.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 13509692
• MDR Text Key: 285450575
• Report Number: 8010047-2022-02778
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131780
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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
• Patient Outcome(s): Hospitalization