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

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.

Event Description

Correction to g3 of the initial medwatch.The aware date should be 23-jun-2021.

Event Description

This supplemental report is being submitted to update section b2.

• 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
• MDR Report Key: 12180793
• MDR Text Key: 261948662
• Report Number: 2951238-2021-00364
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2021,12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDIVATOR AER.; MEDIVATOR AER
• Patient Outcome(s): Required Intervention; Other; Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 68 KG