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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, STERILE; SURGICAL NEEDLE
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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, STERILE; SURGICAL NEEDLE Back to Search Results
Model Number 209012
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/01/2018
Event Type  Injury  
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.
 
Event Description
Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure.The actual device was determined to be available for evaluation.The end user indicated that the eye of the needle broke off during the suturing of a chest tube.The wound was explored by the surgeon.The eye of the needle was not located.No further patient follow-up.The broken needle sample was returned.Upon review of the broken needle, it was noted that marks were identified close to the eye and point of the needle.According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.A review of the samples returned show that the needles were clamped improperly either not on the flat side or too close to the eye or point, which likely caused them to break.Based on this information, the root cause is attributed to customer misuse and no further action is required.
 
Event Description
Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand Name
NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, STERILE
Type of Device
SURGICAL NEEDLE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key8160895
MDR Text Key130254199
Report Number1836161-2018-00128
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number209012
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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