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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP; CLIP, IMPLANTABLE
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US SURGICAL PUERTO RICO PREMIUM SURGICLIP; CLIP, IMPLANTABLE Back to Search Results
Model Number 134046
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 05/05/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during ligation in an open varicocele procedure, there was misfiring of some of the clips which led to bleeding.Some of the clips were malformed.It was noted that the surgeon had managed the bleeding by suturing.
 
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Brand Name
PREMIUM SURGICLIP
Common Device Name
CLIP, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key8751305
Report Number2647580-2019-03443
Device Sequence Number1708794
Product Code FZP
UDI-Device Identifier10884521057548
UDI-Public10884521057548
Combination Product (Y/N)N
Initial Reporter CountryQA
PMA/510(K) Number
K853650
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/01/2019
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 Expiration Date02/28/2023
Device Model Number134046
Device Catalogue Number134046
Device Lot NumberP8B0751CX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/13/2019
Initial Report FDA Received Date07/01/2019
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 Required Intervention;
Patient Age45 YR
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