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 Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject devices were not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.However, as an evaluation result of four ucrs (each serial numbers are (b)(4)) by an olympus local service engineer, there was no defect found.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

It was reported that two intestinal perforations occurred during an unspecified procedure with the ucr.The user assumed that these perforations were caused by an excessive pressure release of the ucr.The user owns four ucrs (each serial numbers are (b)(4)).However, the user did not provide any information, about the condition of the patient or which ucr was used during the procedure, due to patient data protection.No further information was provided.This is the first report of two intestinal perforations.

Manufacturer Narrative

This is a supplemental report to provide additional information.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.The device history record was reviewed and found no irregularities.According to an evaluation result of four ucrs (each serial numbers are (b)(6)) by an olympus local service engineer, there was no defect found.Based on the evaluation result so far, omsc surmised the reported event was attributed to another device, not subject device.

• 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: 8973423
• MDR Text Key: 156890217
• Report Number: 8010047-2019-03221
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other