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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. MEDICHOICE VESSEL LOOPS MAXI RED
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ASPEN SURGICAL PRODUCTS, INC. MEDICHOICE VESSEL LOOPS MAXI RED Back to Search Results
Catalog Number LOOP1004
Device Problems Unsealed Device Packaging (1444); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Aspen surgical received a report from our distributor indicating that vessel loops packages were discovered with sealing issues.Customer alleged that sterility concern was not noticed until after some were utilized in procedures.No injury/death was reported.This is entered in our system as (b)(4).
 
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device will be returned for evaluation.The manufacturing lot numbers were provided for review.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from our distributor indicating that vessel loops packages were discovered with sealing issues.Customer alleged that sterility concern was not noticed until after some were utilized in procedures.No injury/death was reported.This is entered in our system as comp-(b)(4).
 
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that product was found with seal issues.Specifically, they said that when the product was squeezed, air was escaping.The tyvek pouch material is breathable, which allow sterilant penetration while maintaining sterility.The customer was not aware of this characteristic.After testing many samples from the same lot and other lots, those also allowed air to seep out when squeezed, as it should.The products were tested against specifications, and everything performs as it should.Based on this, there is no product malfunction, as the product concern is an expected attribute due to the breathability of the tyvek pouch.If any additional relevant information is discovered, it will be submitted in an additional supplemental report.
 
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Brand Name
MEDICHOICE VESSEL LOOPS MAXI RED
Type of Device
VESSEL LOOPS
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
6945 southbelt dr se
caledonia MI 49316
Manufacturer Contact
terry hall
6945 southbelt dr se
caledonia, MI 49316
6166987100
MDR Report Key18890782
MDR Text Key337761237
Report Number3002750084-2024-00007
Device Sequence Number1
Product Code KDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLOOP1004
Device Lot Number339143, 310386
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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