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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN/MEDTRONIC / COVIDIEN ENDO CLIP APPLIER; CLIP, IMPLANTABLE
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COVIDIEN/MEDTRONIC / COVIDIEN ENDO CLIP APPLIER; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 176620
Device Problems Corroded (1131); Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 07/13/2020
Event Type  malfunction  
Event Description
Medtronic clip appliers, reloads, staplers and endo gia have been delivered with fod.The fod appears to be metal shavings, black particles, and fuzz in the sterile packaging.(b)(6) healthcare has found these issues at receiving prior to delivery to the operating room.We have notified medtronic of over 50-75 instance along with picture and product.Medtronic has yet to provide quality assessment to the finding.We do not feel as though this is being taken seriously as the events did not touch a patient or impact the operating room.If these items were not caught prior to surgery, there would have been a potential adverse affect/impact to the patient and / or staff.Fda safety report id# (b)(4).
 
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Brand Name
ENDO CLIP APPLIER
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN/MEDTRONIC / COVIDIEN
MDR Report Key10384514
MDR Text Key202417106
Report NumberMW5095966
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/06/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number176620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age1 YR
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