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 Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On january 22, 2021, olympus medical systems corp.(omsc) received the literature titled "outcome of peroral endoscopic myotomy in children with achalasia".This study was conducted on the peroral endoscopic myotomy (poem) for 43 children with achalasia between september 2013 to january 2018.In the literature, it was reported 7 patients of accumulation of retroperitoneal co2, 3 patients of capnoperitoneum, and an intra-procedural mucosal injury.Based on the available information, the intra-procedural mucosal injury was reported as a nonreportable event.Whereas, the accumulation of retroperitoneal co2 and capnoperitoneum were reported as insufflation-related events and intervention required events.Therefore, omsc assumes that these 7 patients of accumulation of retroperitoneal co2, 3 patients of capnoperitoneum might be related to the subject device.Based on the available information, detailed information on the subject device was not provided.There is no description of the device's malfunction.Omsc will submit a medical device report (mdr) of the subject device for an intervention required events.

• 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: 11270841
• MDR Text Key: 233110030
• Report Number: 8010047-2021-02154
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/03/2021

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/02/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention