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

Model Number UHI-4

Device Problem Increase in Pressure (1491)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

E1 address: (b)(6).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during pneumoperitoneum for laparoscopic hysterectomy, pelvic lymph node dissection using this high flow insufflation unit, the patient developed bradycardia and transient asystole (6-8seconds).The event occurred at the beginning, thirty minutes after pneumoperitoneum has started.There was no obvious warning, as reported.It was treated as strong parasympathetic response from patient and atropine was given on top of requested for deflation of pneumoperitoneum.There was a delay for several minutes to ensure patient was stabilized after the transient asystole before proceeding.The device was inspected before use for tube obstruction and excessive pressure.The procedure was completed, and the current patient status is well, as reported.The set pressure was 15 mmhg.The cavity pressure was not exceeding 15mmhg.The cavity pressure was stable during procedure, as reported.Patient had normal body mass index.Inspection records were received and found error e03, excessive pressure when inflated-pressure sensor abnormality, in log.

Event Description

It was reported the flow rate setting was normal.The overpressure warning did not beep, and the overpressure light did not occur.The smoke evacuation suction tube was connected.It is unknown whether overpressure occur, therefore the timepoint of overpressure occurrence is also unknown.The user reported that it is unknown whether intra-abdominal pressure (iap) was high when the reported adverse incident occurred.The equipment has not been used after inspection and no similar problems have occurred.Additionally, it was reported the patient's body mass index (bmi) was 22.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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, the reported event could not be replicated.However, it was determined that bradycardia is not accompanied by overpressure, and it is not possible to confirm that the overpressure is caused by the operation of the device.Therefore, it is not considered that the malfunction of the main substrate tube pressure sensor is also relevant.The root cause of the reported event could not be identified.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: 18237053
• MDR Text Key: 329433000
• Report Number: 3002808148-2023-13507
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 11/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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: INSUFFLATION TUBING BY KARL STORZ; INSUFFLATION TUBING WITH LUER LOCK KARL STORZ; TROCAR & CANNULA (30123TS1/L1/C) KARL STORZ; TROCAR & CANNULA 11MM WITH CAP BY KARL STORZ
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 50 YR