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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 Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 10/02/2020
Event Type  Injury  
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). 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 patients 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 patients current condition is reported as deceased. The patients 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.
 
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Brand NameEVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of DeviceGASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key12180793
MDR Text Key261948662
Report Number2951238-2021-00364
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 06/23/2021,07/16/2021
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? No
Device Operator
Device Model NumberGIF-1TH190
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/23/2021
Event Location Hospital
Date Report to Manufacturer06/23/2021
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/16/2021 Patient Sequence Number: 1
Treatment
MEDIVATOR AER
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