MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GASTROINTESTINAL VIDEOACOPE; GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-LV1

Device Problems Fluid/Blood Leak (1250); Residue After Decontamination (2325)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus¿s local distributor, but not returned to omsc.Therefore the exact cause of the reported event could not be conclusively determined at this time.Olympus¿s local distributor confirmed the following information.It found leakage between the c-cover and the c-body for the scope.There was debris inside the channel.A supplemental report will be submitted if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the user, it found leakage from the a-rubber.There was no report of patient injury associated with the event.On (b)(6) 2021, omsc was informed that during the inspection for repair at the local service department of olympus, there was debris inside the channel.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus¿s local distributor, but not returned to aizu factory.Therefore the exact cause of the reported event could not be conclusively determined at this time.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Besides, omsc confirmed the following additional information.-manufacturing date: aug 6, 2014 the repair department found foreign material in a channel of the subject device at incoming inspection for repair.The cause of the suggested event is difficult to specify, and omsc presume the following based on investigation result: ¿pre-cleaning was not performed immediately after the procedure, which caused the material difficult to remove.¿the device was not properly brushed or water flow was not adequate at pre-cleaning and/or manual cleaning, which caused the material difficult to remove.If additional information becomes available, this report will be supplemented.

• Brand Name: GASTROINTESTINAL VIDEOACOPE
• 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: 12286139
• MDR Text Key: 265593728
• Report Number: 8010047-2021-09885
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K111756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GIF-LV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1