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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) ESOFLIP; ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE

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COVIDIEN AG JUAREZ (MMJ) ESOFLIP; ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE Back to Search Results
Model Number ES-330
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Perforation of Esophagus (2399)
Event Date 05/04/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the catheter passed pre-use check.When they took the catheter out and when back in with the scope, they saw a perforation.The patient had a torturous esophagus.They put a stent in to help with drainage.The patient has an existing condition of achalasia.The patient was doing fine.
 
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Brand Name
ESOFLIP
Type of Device
ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE
Manufacturer (Section D)
COVIDIEN AG JUAREZ (MMJ)
1181 hennequen ave.
juarez,chi 32575
MX  32575
Manufacturer (Section G)
COVIDIEN AG JUAREZ (MMJ)
1181 hennequen ave.
juarez,chi 32575
MX   32575
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key11912110
MDR Text Key253480909
Report Number9681384-2021-00012
Device Sequence Number1
Product Code PIE
UDI-Device Identifier05391530810043
UDI-Public05391530810043
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/01/2021
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
Device Operator Health Professional
Device Expiration Date08/21/2022
Device Model NumberES-330
Device Catalogue NumberES-330
Device Lot Number20H0545JZ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received06/01/2021
Date Device Manufactured08/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
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