Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA VESSEL LOOPS, RED, MINI, STERILE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPEN SURGICAL PRODUCTS, CALEDONIA VESSEL LOOPS, RED, MINI, STERILE Back to Search Results
Model Number 011001PBX
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not available.
 
Event Description
Aspen surgical received a medwatch report (uf/importer # (b)(4)) indicating that the end user reported that two mini vessel loops broke during a procedure.No injury or death reported.This report was filed in our complaint handling system as number (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VESSEL LOOPS, RED, MINI, STERILE
Type of Device
VESSEL LOOPS
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
6165367508
MDR Report Key10804546
MDR Text Key216907636
Report Number1836161-2020-00056
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number011001PBX
Device Lot Number211275
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-