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

Model Number UHI-3

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The referenced high flow insufflation unit was returned to the service center for evaluation of the reported "pressure settings kept jumping up randomly".A visual inspection was performed and found rust on the bottom chassis and multiple deep scratch marks on top cover.However, the front panel switches and selected settings were operational.The pressure, flow rate, and volume adjusted accordingly.The relief mode, warning tones of excessive pressure, and tube obstruction functioned properly.The warning against excessive peritoneal cavity pressure was working properly as the pinch valve worked appropriately and restored pressure to preset within 10 seconds once over-pressuring was detected.Additionally, the device was left on for an hour, noted the gas supply remained stable, and no air leakage.The pressure settings was also stable, and did not keep jumping up 40 or change the values randomly.However, during a second inspection, the service group found the pressure indicator's two green leds light up at the same time.This condition occurred intermittently due to a faulty main board.However, it does would not contribute to the reported event.A review of the service history revealed no service records for the high flow insufflation unit.The cause of the reported "pressure settings kept jumping up randomly" could not be confirmed as the pressure settings worked appropriately.As a preventive measure, the instruction manual notes, if excessive pressure warning continually sounds, it could be excessive gas volume released from other equipment.Reduce gas volume released from other equipment.Additionally, the instruction manual indicates to, never connect the suction tube and the insufflation tube to the same veress needle or trocar.Doing so will impede measurement of the abdominal pressure which may result in excessive abdominal pressure, or make it impossible to maintain the selected abdominal pressure.If the insufflator emits a warning (warning light or alarm)for intra-abdominal over-pressurization, quickly open the stopcock or valve of the trocar.

Event Description

The service center was informed that during an unspecified procedure, the high flow insufflation unit reportedly exhibited excessive pressure during inflation as the "pressure settings kept jumping up randomly".There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to update section h4 and to provide additional information from the oem.The oem performed a device history record (dhr) review with no abnormalities found.The product was not returned to oem for investigation.Inspection reports were not available.The cause could not be identified because there was no delivery of the product and the inspection report was not available.

• 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: 9432855
• MDR Text Key: 219572269
• Report Number: 8010047-2019-04193
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1