MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-3

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could be duplicated.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.

Event Description

Olympus medical systems corp.(omsc) was informed that during the gastrointestinal surgery, the subject device was used with foot switch mh-317.The user stepped on the mh-317 to exhaust smoke, but when the intra-abdominal pressure became +5 from the set value, the pinch valve kept opening without stepping on the mh-317.The abdominal pressure dropped.After the trouble occurred, the procedure was continued by manually operating the cock of the trocar without using mh-317, and completed.There was no report of patient injury associated with the event.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could be duplicated.The manufacturing record was reviewed and found no irregularities.Omsc judged that the pinch valve kept opening and the abdominal pressure dropped because the internal mechanism of the foot switch failed.The caused of foot switch failure could not be identified, but it was presumed that load more than expected was applied on the pedal part and it was damaged.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12567086
• MDR Text Key: 274446532
• Report Number: 8010047-2021-12636
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1