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

Model Number UCR

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

Patient Problems Fever (1858); Pneumonia (2011); Injury (2348)

Event Type  Injury  

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 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) month-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 3 of 6 reports.(3rd of 6 patients).

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9760709
• MDR Text Key: 194606310
• Report Number: 8010047-2020-01525
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239748
• UDI-Public: 04953170239748
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: UCR
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other