MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It is reported in the literature article "short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis" appearing in volume 92, no.3: 2020 of the gastrointestinal endoscopy journal, that a patient experienced a procedure related adverse event following a single pyloromyotomy using a gastroscope, transparent distal cap attachment, insufflation device, and either a hybrid knife i-type (erbe-germany) or a hookknife.This patient experienced the adverse event of tension capnoperitoneum.The patient was treated with needle decompression and recovered without any consequences.This event occurred sometime between june 2015 and march 2018.Cross reference mfr: 8010047-2020-07396.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10648554
• MDR Text Key: 210435305
• Report Number: 2951238-2020-00504
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020,10/08/2020

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: UCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EITHER HYBRID KNIFE TYPE-I (ERBE) OR HOKKNIFE; GIF-H190; MH-588
• Patient Outcome(s): Other; Required Intervention