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

Model Number UHI-4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Tachycardia (2095)

Event Type  Injury  

Manufacturer Narrative

E1: (b)(6) hospital.The device was returned to olympus for evaluation and found no abnormality on visual inspection, device check and operation check.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported at the end of total laparoscopic hysterectomy with bilateral salpingo-oophorectomy procedure, the high flow insufflation unit tube was extubated from the patient and the patient developed arrythmias.The cardiologist diagnosed tachycardia and persistent atrial fibrillation and patient was started anticoagulation therapy.The patient was given an atp (adenosine triphosphate) preparation for an hour, but there was no improvement, so defibrillation was performed.The procedure was completed with the same set of equipment.There were no abnormalities in the procedure, and the patient was discharged on the fourth postoperative day without any difficulty in routine activities/daily life.No pre-existing medical conditions were noted.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18632510
• MDR Text Key: 334445941
• Report Number: 3002808148-2024-01050
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 02/02/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female