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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP
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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP Back to Search Results
Model Number HX-202UR
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event 08/28/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The service center was informed that during an unspecified procedure, a third clip failed to deploy and when retrieving the clip it caused a tear to the patient¿s mucosa, with bleeding.The bleeding was controlled with an unknown device.It was reported that the end user had experienced deployment issues with two clips prior to the incident and these clips were not used on the patient.The intended procedure was completed with a competitor¿s device.
 
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Brand Name
SINGLE USE REPOSITIONABLE CLIP
Common Device Name
SINGLE USE REPOSITIONAL CLIP
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key9124207
Report Number2951238-2019-01129
Device Sequence Number11540088
Product Code PKL
UDI-Device Identifier04953170385933
UDI-Public04953170385933
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/26/2019
Report Date (Section F) 08/29/2019
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? Yes
Operator of Device Health Professional
Device Model NumberHX-202UR
Device Lot Number91K
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/29/2019
Event Location Hospital
Date Report to Manufacturer08/29/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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