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

Model Number GIF-H190

Device Problem Microbial Contamination of Device (2303)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center and pending evaluation. An investigation is ongoing to obtain additional information regarding the reported event. If additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that a gastroscope used on a patient with carbapenem-resistant enterobacteriaceae (cre), cultured positive twice for less than one csu/ml gram variable rod after reprocessing. There were no associated patient infections reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and lm investigation. A visual inspection was performed on the received condition and found stains inside of the biopsy channel. An olympus boroscope was used to inspected the biopsy and suction channels. The first inserted the boroscope into the biopsy channel and noted, stains near the control body side and scrapes throughout. The suction channel was also inspected using the boroscope, and there were no abnormalities found. The video scope passed the cosmo leak test (+. 2). The video scope was purchased on (b)(6) 2019. Additional findings include; non-olympus c-cover, non-olympus switch 1, non-olympus bending section cover and glue, non-olympus insertion tube, non-olympus light guide tube. The legal manufacturer (lm) reviewed the content of this complaint for further investigation. The lm reports that the root cause could not be identified. The legal manufacturer provided the following possible cause for the reported event are presumed as follows: since the subject device was repaired by a third-party agency, olympus cannot secure its quality. We cannot conclusively specify the cause of the suggested event for the user declined confirmation of reprocessing by the ess or culture test by the third-party labs. The suggested event may have occurred by the following causes. Reprocessing process conducted by the user was different from the process recommended in ifu. As a result, the device was reprocessed insufficiently. Insufficient reprocessing due to third-party repair. Contamination occurred at culture sampling by the user. Ifu states 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. Ifu states that third-party repair is excluded from olympus¿ limited warranty in prohibition of improper repair and modification as follows: this instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner. The legal manufacturer confirmed the subject scope was shipped in accordance with specifications via dhr.

• 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: 11985155
• MDR Text Key: 269762076
• Report Number: 8010047-2021-07412
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse