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

Model Number GIF-1TH190

Device Problem Microbial Contamination of Device (2303)

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

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp. (omsc) was informed that as the results of multiple microbiological testing for positive by the user facility, following microbes were detected in the sample collected from the subject device as follows; [first time; (b)(6), 2021] olympus medical systems corp. (omsc) was informed that as the results of multiple microbiological testing for positive by the user facility, following microbes were detected in the sample collected from the subject device as follows; [first time; (b)(6), 2021] klebsiella pneumoniae: < 10 cfu escherichia coli: 10-100 cfu [second time;(b)(6), 2021] klebsiella pneumoniae: < 10 cfu escherichia coli: < 10 cfu other detailed information such as the reprocessing method was not provided. There was no report of infection associated with this report.

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4). Olympus (b)(4) checked the subject device and found following; - the light guide lens was chipped and cracked - the adhesive around the lens was worn - the distal end cap had dents and scratches - the angulation had slack - the bending angle did not meet specification - the bending rubber adhesive was detached - the insertion tube was buckled and the coating was peeled off - the connecting tube was deformed. - the control section, the s-cover and scope connector case were deformed the exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information. Olympus (b)(4) requested the user three times to provide the information regarding the reprocessing, however the user did not provide it. Therefore olympus (b)(4) could not obtain it. Since the subject device was not returned to olympus medical systems corp. (omsc), it could not be investigated. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined. If additional information becomes available, this report will be supplemented.

• 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: 12194486
• MDR Text Key: 280902287
• Report Number: 8010047-2021-09091
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No