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

Model Number GIF-Q150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) reviewed a sales record and confirmed that the subject device was installed to the user facility in 2012.In addition, (b)(4) reviewed the service history of the subject device and confirmed that there was no maintenance performed by (b)(4) until the event occurred.The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that an unspecified diagnostic procedure, the user facility noticed that the patient¿s pharynx was slightly injured by the subject device.The patient complained of nausea and bloody saliva was observed.The user facility alleged that the pharyngeal injury occurred due to rough surface of the insertion section of the aging subject device.There was no report of further patient injury with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.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.However, eight years have passed since the subject device was installed to the user facility, and maintenance was not performed by olympus during the period of use.Therefore, it is surmised that the reported event occurred because the subject device was used in a condition that the insertion section of the subject device was significantly deteriorated.The instruction manual of the device has already warned as follows; the probability of failure of the endoscope and ancillary equipment increase as the number of procedures performed and/or the total operating hours increase.In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically.An endoscope with which an irregularity is suspected should not be used, but should be inspected by following section 5.1, ¿troubleshooting guide¿ on page 52.If the irregularity is still suspected after inspection, contact olympus.

• Brand Name: 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: 9400675
• MDR Text Key: 175023185
• Report Number: 8010047-2019-04139
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170229435
• UDI-Public: 04953170229435
• Combination Product (y/n): N
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GIF-Q150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other