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

Model Number UHI-4

Device Problem No Flow (2991)

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

Event Type  malfunction  

Event Description

The regional repair center (ofr) was informed that a customer high flow insufflation unit was returned for a reported "insufflation impossible to perform during a procedure".During the inspection and testing, after starting up the insufflator went into alarm mode with no indicators displayed on the front panel (reportable).It was identified that this failure was related to a malfunction of the (cr) circuit board.No patient injury or harm was reported to olympus.

Manufacturer Narrative

The service evaluation was confirmed the customer reported issue as the insufflator went into alarm m the investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.Ode and no indicators displayed on the front panel.It was identified that the issue was related to a malfunction of the (cr) circuit board.The product was sold in june 2016 and has not been previously repaired.

Event Description

The reported event occurred during nephrectomy by coelioscopy procedure.The referenced insufflator stopped working three times during use.The procedure was completed with use of other equipment.There was an additional operating time of thirty minutes.No patient complications were reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional details regarding the event (b5).

Manufacturer Narrative

This supplemental report is to inform that upon further review, the reportable malfunction has been submitted twice.Refer to medwatch 8010047-2021-16110 (patient identifier (b)(6)) for investigation results.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13233289
• MDR Text Key: 289537101
• Report Number: 8010047-2022-01285
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

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: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/17/2022; 03/16/2022
• Supplement Dates FDA Received: 01/27/2022; 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1