MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Electrical /Electronic Property Problem (1198); Excess Flow or Over-Infusion (1311)

Patient Problem Hypoxia (1918)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report was returned to olympus; however, evaluation has not yet been completed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.The fda form 3500 for health professionals is attached for additional information.This report has been submitted by the importer under this mdr report number 2429304-2023-00361.

Event Description

Olympus received an fda form 3500 for health professionals reporting an event involving the high flow insufflation unit used in a right adrenalectomy laparoscopy with the patient under general anesthesia.Per the operative note after the time out was performed, a veress needle was placed in the right subcostal area.The abdomen was insufflated to a pressure of 15 mmhg without any adverse hemodynamic consequences.A 5 mm laparoscope was introduced into the abdomen using a 5 mm optical trocar above the umbilicus around 2 fingerbreadths below the xiphoid.General inspection of the abdomen revealed no obvious pathology and no injury from the veress needle.The anesthesia record then documented that at 13:52, the patient's saturation and end tidal co2 dropped suddenly after insufflation started.The surgeon was notified.The patient was placed on 100% oxygen.The patient had equal bilateral breath sounds and no crepitus was detected.The endotracheal tube (ett) was suctioned.The patient was easy to ventilate, and peak pressures were acceptable.There was no disconnect detected and the orogastric tube was in place.Another anesthesiologist was consulted for a second opinion and the surgeon was asked to release pneumoperitoneum.The patient's saturation and end tidal co2 began to rise and stay stable.Alveolar-arterial oxygen (aa) gradient and low potassium were detected on i-stat.There was no further incident reported.The customer noted that the olympus high flow insufflation unit uhi-4 was used during the procedure.This device is subject of an fda class 1 recall because "the unit may over-insufflate (inflate) air into the body with no warning or alarm." per interview with the surgeon in this case, the pressure reading on the insufflator device was within normal limits and there was no alarm.However, the abdomen was tense, and the patient was desaturating.The patient stabilized after releasing pneumoperitoneum.The same insufflator and tubing were used for the remainder of the case without any issue.There was no further patient harm reported.

Event Description

Olympus received further information from the customer.Anesthesia was started at 12:33, incision time was 13:40, and at 13:52, the patient's saturation and end tidal co2 dropped.The patient was discharged on october 9 and is doing well and at baseline.

Manufacturer Narrative

This report is being supplemented to provide additional information as reflected in b5 and the device evaluation results.Please see updates to b2, h6, and h10.The device was returned to olympus for evaluation.Visual inspection on as received condition found no physical damage to the gas inlet, co2 gas insufflation connector, and pinch valve except minor scratches on the top cover.All the interior tubes are clean, with no biomaterial present.The front panel switches, indicators, and buzzer/alarm sounds are also working properly.The device was checked with olympus' test equipment and co2 gas cylinder and no gas leakage from primary and secondary piping was observed.The smoke evacuation function and the supply pressure sensor operation work properly.The abdominal cavity excessive pressure was checked and passed the inspection as its warning generated with the abdominal cavity pressure setting of +/-5mmhg or more, and after excessive pressure warning, the pinch valve was able to activate to achieve the set pressure.The device also passed the measurable inspection such as the flow rate measurement accuracy check, average integrated flow rate check, abdominal cavity pressure control of both small/normal check, and the relief control check and are all within specification.Based on the evaluation findings, the uhi-4 is functioning properly as intended.The device was further inspected by the electronics service line.The lead technician was able to confirm the user request, "issue with a patient with the insufflator".Initially, the unit failed the small cavity control check the first two times.The unit stopped insufflation at 17 mmhg pressure.Passing range is 14 mmhg to 16 mmhg.The test was redone 5 more times and passed each time after.Intermittent failure was noted with unknown cause.There were also minor scratches on the housing.The customer's original settings were as follows: cavity mode was set normal.Set pressure indicator was at 3 mmhg.Flow rate was set low mode at 1.0l/min.Smoke evac was set off mode.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional information received: error logs checked verifies e03 line pressure sensor error had occurred three time, confirming that the line pressure sensor was malfunctioning.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, although the reported event has not been reproduced, it has been determined that high overpressure due to small intra-abdominal pressure fluctuations in a state of low anesthesia.In addition to the device, it is likely that overpressure is caused by the anesthetic condition on procedure.Although the abnormal behavior has not been confirmed from the operation log, the relevance to the malfunction of the main substrate tube pressure sensor has not been denied.The root cause of the reported event have not been identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information as reflected in b5.

Event Description

Olympus received further information indicating that the device pressure was set to 15 mmhg, flow rate was set on high, insufflation pressure was indicated for 15 mmhg, and that the indication for insufflation pressure was stable.There was no other gas source used other than the uhi-4.The warning for overpressure and tube clogging did not beep nor did the overpressure warning light occur.The 37-year-old patient had a regular body size and was not obese.It was confirmed that the patient's abdominal cavity was abnormally distended.The overpressure occurred during laparotomy and right adrenalectomy.Insufflation was performed in that cavity and the aforementioned procedure reportedly caused the overpressure.It was determined that the intra-abdominal pressure was high through palpation and due to desaturation of the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's further evaluation findings and investigation results.The additional evaluation findings are as follows: e03 line pressure sensor error.Circuit board (cr-board) intermittently going blank with a sounding alarm.Based on the additional investigation findings, it was determined that the e03 line pressure sensor error was caused by a defective cr-board.Also, the cessation of the air supply operation and the alarm noise was due to the error.However, the root cause could not be determined.This supplemental report includes information added to h6.Olympus will continue to monitor field performance for this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18182515
• MDR Text Key: 328742489
• Report Number: 3002808148-2023-13166
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/28/2023; 12/22/2023; 04/01/2024; 05/08/2024
• Supplement Dates FDA Received: 12/05/2023; 01/02/2024; 04/08/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Treatment: OPTIVIEW, ETHICON TROCAR; UNKNOWN TUBING
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic