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

Model Number	UCR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature title "peroral endoscopic myotomy in children with achalasia: a relatively long-term single-center study".The literature reported the result of 21 cases of the peroral endoscopic myotomy (poem) using olympus model ucr between october, 2014 and october, 2016.In the 21 cases of the poem, the six patients developed complications.The first patient who was (b)(6) old girl, developed subcutaneous emphysema and pneumoperitoneum, which manifested as subcutaneous emphysema in the head, neck, anterior chest, and emphysema in the abdomen during the operation.This patient received abdominocentesis and her emphysema recovered.The second patient developed subcutaneous and mediastinal emphysema during the operation, which spontaneously resolved as revealed by chest x-ray.Additionally four patients developed subcutaneous or mediastinal emphysema as postoperative complications, which were manifested by postoperative x-ray or ct scans.One of four patients developed fever and symptoms of pneumonia, however, recovered after antibiotics administration.Further detailed information could not be obtained from the user facility at present.According to the number of the number of patients, omsc is submitting 6 medical device reports.This is 4 of 6 reports.(4th of 6 patients).

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Common Device Name: 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: 9760722
• Report Number: 8010047-2020-01526
• Device Sequence Number: 10934889
• Product Code: HIF
• UDI-Device Identifier: 04953170239748
• UDI-Public: 04953170239748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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
• Operator of Device: No Information
• Device Model Number: UCR
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other