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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT Back to Search Results
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.
 
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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 Key10648492
MDR Text Key216407946
Report Number8010047-2020-07396
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170239113
UDI-Public04953170239113
Combination Product (y/n)N
PMA/PMN Number
K081173
Number of Events Reported1
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 NumberUCR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/08/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received12/11/2020
Supplement Dates FDA Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EITHER HYBRID KNIFE I-TYPE (ERBE) OR HOOKKNIFE; GIF-H190; MH-588
Patient Outcome(s) Other; Required Intervention;
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