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 Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

No device was returned to olympus for evaluation.There is no report of device malfunction in this case.No specific patient information is available at this time.Additional information is being pursued.Upon receipt of additional relevant details, this report will be updated.

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.

Manufacturer Narrative

This report is being submitted to report investigation results.A review of the device history record (dhr) could not be conducted, as no serial number was provided.Olympus conducts comprehensice quality inspections on all devices prior to shipment, and doe not ship any device that does not meet specifications.No containement measures are warranted.At this time there is no information to suggest that the reported event may expand.Conclusion: no device malfunction was reported.The definitive cause of the event is not established.

• 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: 10648492
• MDR Text Key: 216407946
• Report Number: 8010047-2020-07396
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• 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,l
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EITHER HYBRID KNIFE I-TYPE (ERBE) OR HOOKKNIFE; GIF-H190; MH-588
• Patient Outcome(s): Other; Required Intervention