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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-1TH190
Device Problems Device Reprocessing Problem (1091); Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Drug Resistant Bacterial Infection (4553)
Event Date 10/02/2020
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has been returned to olympus for third party laboratory culturing and physical evaluation (after culturing and eto sterilization).The scope is currently with the third party laboratory undergoing culturing.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 - 2021 - 00364.
 
Event Description
The customer reported after being notified by the state board of health, a cluster of six gastroenterology patients have been diagnosed with the same strain of carbapenemase-producing pseudomonas aeruginosa (cppa) during a six-month period.All six patients were found to have undergone procedures using the same evis exera iii gastrointestinal videoscope.Patient 1 of 6 is reported in case with patient identifier (b)(6).Patient 2 of 6 is reported in case with patient identifier (b)(6).(this report) patient 3 of 6 is reported in case with patient identifier (b)(6).Patient 4 of 6 is reported in case with patient identifier (b)(6).Patient 5 of 6 is reported in case with patient identifier (b)(6).Patient 6 of 6 is reported in case with patient identifier (b)(6).In this patient case: eight days after an endoscopic ultrasound (eus)/esophagogastroduodenoscopy (egd) with stent placement using an evis exera iii gastrointestinal videoscope, the patient had blood culture results showing: pseudomonas aeruginosa, carbapenem resistant (carbapenemase producer).The patient required unspecified treatment due to the infection.The indication for the procedure was malignant tumor of the head of pancreas, gastric outlet obstruction, duodenal stenting, and staging of malignant ascites.The patient¿s history was significant for: metastatic pancreatic adenocarcinoma, gastric outlet obstruction, diabetes mellitus (dm), and admission from hospice care for vancomycin resistant enterococcus (vre) bacteremia.The patient¿s current condition is reported as deceased.The patient¿s cause of death is not known to be associated with the device at this time.Cause of death has been requested, but not provided at the time of this report.The customer verified there was no malfunction of the olympus scope during the procedure.The customer reports after becoming aware of these events, the scope was immediately quarantined.The suspect scope was cultured, and all cultures were negative for pseudomonas aeruginosa.The customer also reports the suspect scope was carefully examined with no abnormalities noted.No breaches were found from standard high-level disinfection processes.
 
Manufacturer Narrative
This report is being updated to report investigation findings.New information is reported in b1, d8, d9, h6, and h10.The device history record (dhr) was reviewed, and it was confirmed the device was shipped in accordance with specifications.Table summary of patient procedures: -case#; pt.#- complaint # -patient- -procedure- -sampling- case1;pt.1/6 (b)(4), 65 y/o female (b)(6) 2020 ,(b)(6) 2020, case2;pt.2/6 (b)(4), 60 y/o female (b)(6) 2020 ,(b)(6), 2020, case3;pt.3/6 (b)(4), 74 y/o female (b)(6) 2020 ,(b)(6) 2020, case4;pt.4/6 (b)(4), 63 y/o male (b)(6) 2021 ,(b)(6) 2020, case5;pt.5/6 (b)(4), 58 y/o male (b)(6) 2021,(b)(6) 2021.Case6;pt.6/6 (b)(4), 60 y/o male (b)(6) 2020 to (b)(6), 2021.*pt.6/6 had 6 procedures in total within the above period physical inspection of the device after period of scope use two: ((b)(6) 2020-(b)(6) 2021) there is leakage from biopsy channel.Channel cover has deep scratches.Deep scratches.The ob-lens is chipped.The rubber glue is chipped.Physical inspection of the device after period of scope use three: ((b)(6) 2021- (b)(6) 2021) small black debris was noted at 170mm from the distal end opening.A kink was found on the channel wall of the connecting tube, approximately 65mm from the suction cylinder.A kink was confirmed in suction channel located approximately 120mm from the opening of the connector.The opening of the auxiliary channel at the distal end side has debris.Scratches were present on the insertion tube close to the boot.A kink was confirmed in lg-tube near control section.The scope passed leakage test.An endoscopic support specialist (ess) provided education to the facility on four different occasions between (b)(6) 2019 and (b)(6) 2021.((b)(6) 2019, (b)(6) 2020, (b)(6) 2020, and (b)(6) 2021.The purpose of the education: review scope handling and reprocessing of scopes.Session: general overview and demonstration of handling scopes during procedures and while transporting, along with reprocessing (pre-clean through drying).Lastly, common scope repairs olympus receives from the user were reviewed.No gaps in reprocessing procedures were observed during these times.Third party lab culturing of the scope showed: insertion section: positive: bacillus subtilis air/water channel: positive: negative biopsy channel: positive: pseudomonas aeruginosa (not specified whether it was cppa or not) auxiliary water channel: positive: brevibacillus species the customer approved destructive testing of the device to help determine root cause.Results of destructive testing performed (b)(6) 2021 showed: 1- evaluation of disassembled scope connector: trace of the previous repair and water invasion 2-evaluation of disassembled control section: suction channel is kinked.No evidence of water invasion, internal corrosion, or adhered debris 3-evaluation of suction channel and air/water channel: performed leakage test by soaking.No leakage found.4-evaluation of bending section: braids: no abnormality.Biopsy channel distal end side: slightly stained.5-evaluation of biopsy channel: no leakage confirmed by soaking.White debris and black debris inside the channel.6-evaluation of biopsy channel white debris: protein like spectrum was detected by fourier transform infra-red spectography (ft-ir).7-evaluation of biopsy channel black debris: the debris had black are and translucent black area.Black area: possibly silicone related black debris such as black silicone rubber translucent area part: possibly calcium soap, product of hard water and fatty acid 8-evaluation of glue between cover body and cover: no trace of corrosion or debris confirmed at glue no debris found at channel opening of biopsy channel no trace of corrosion or debris confirmed at glued area of all channels or pipe on cover body 9-evaluation of glue between control body and cover-area 2 debris noted at channel opening of auxiliary water channel confirmed seepage of glue fixing cover in channel.Seepage of glue occurs at assembly.No abnormality such as narrowed channel.No debris other than the glue.10-evaluation of lever mount: white dot like stains in the channel.Unable to analyze by energy-dispersive x-ray spectography (eds).11-evaluation of suction cylinder and air/water cylinder: trace fragments of cleaning brush.No corrosion or adhered debris 12-evaluation of inside the nozzle: no debris in the nozzle 13-evaluation of connecting mouthpiece on auxiliary water channel in control section: brown debris around the mouthpiece.Eds result: molycote & organic substance, rusty iron & organic substance.Ft-ir result: organic substance is possibly mixture of carboxylic salt and rust, originated from chemical solution and/or tap water.White powder inside the mouthpiece: unable to analyze by eds.Conclusion summary: the definitive root cause of the reported events cannot be specified.Olympus received the scope as an adverse event complaint after period of the scope use three and the following information was provided.According to the information from the user, reprocessing procedures conducted by the user was not deviated from instructions for use (ifu).Although the subject scope had been used for over 200 patient procedures during the same time period the cluster occurred, only the six patients were infected.Moreover, each infection was identified at various time.After the scope was used for patient, the subject scope was repaired for leakage by olympus.The result of culture test was negative when the test was performed at the user facility, when culture test was performed by the third-party labs, pseudomonas aeruginosa (unspecified if it was cppa) was detected from biopsy channel.White debris was detected from biopsy channel.According to ft-ir analysis, protein like spectrum was confirmed.Additionally, a translucent black debris was found in the biopsy channel.We cannot rule out the possibility that the debris remained adhered during reprocessing.The instructions for use warns on insufficient reprocessing as follows: reprocessing manual:1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (per capa-200413).It has been over 7 years since the subject device was manufactured.Based on the results of the additional investigation, the following was determined: 1.A cluster of six patients had been diagnosed with the same strain of cppa ¿ although the root cause could not be determined, only 6 patients out of 200 in which the device was used were infected.In addition, the reprocessing process conducted by the user did not deviate from the instructions for use (ifu).2.Positive in culture test ¿ although the root cause could not be determined, the result of the culture test was negative when the test was performed at the user facility.In addition, when culture test was performed by the third-party labs, pseudomonas aeruginosa was detected from biopsy channel.Whether it was cppa or not was unknown.3.Debris inside of auxiliary water channel ¿ the foreign material at the channel opening of the auxiliary water channel was the adhesive that fixes the c-cover.It is likely that seepage of glue may have occurred during assembly of the device.The foreign material at the connecting mouthpiece on the auxiliary water channel in the control section may be the mixture of moly cote, carboxylates, and rusts.It could not be determined why the foreign material remained.According to the customer¿s reprocessing process for the areas where foreign material remained, obvious deviation from ifu was not confirmed.4.Small black debris/stain in biopsy channel - although the white and black debris (black part and translucent black part) couldn't be identified, the component analysis indicated that it is likely that the white debris is protein, the black debris (black part) is originated from silicon, and the black debris (translucent black part) is a possibly calcium soap that the mixture of hard water and fatty acid.It could not be determined why the foreign material remained.According to the customer¿s reprocessing process for the areas where foreign material remained, obvious deviation from ifu was not confirmed.5.White stain in the k-mount ¿ although the root cause could not be determined, it was confirmed that there was a white stain at the k-mount.However, the specifics of the white stain could not be identified.It could not be determined why the foreign material remained.According to the customer¿s reprocessing process for the areas where foreign material remained, obvious deviation from ifu was not confirmed.Olympus will continue to monitor field performance for this device.
 
Manufacturer Narrative
This supplemental report is being submitted to update section b2.
 
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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 Key12180826
MDR Text Key262208721
Report Number8010047-2021-08963
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170343360
UDI-Public04953170343360
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGIF-1TH190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MEDIVATOR AER
Patient Outcome(s) Death; Required Intervention; Other;
Patient Age60 YR
Patient SexFemale
Patient Weight68 KG
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