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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERSAONE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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COVIDIEN LP LLC NORTH HAVEN VERSAONE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number RSEAL
Medical Device Problem Code Packaging Problem (3007)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/22/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, following lab evaluation, the seal used with the metal port had a slight tear.There was no damage observed at the beginning of the evaluation when the packaging of the two ports was first opened.
 
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Brand Name
VERSAONE
Common Device Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key12012466
Report Number1219930-2021-02396
Device Sequence Number14562844
Product Code GCJ
UDI-Device Identifier20884521785813
UDI-Public20884521785813
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2025
Device Model NumberRSEAL
Device Catalogue NumberRSEAL
Device Lot NumberN0L0167UY
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2021
Initial Report FDA Received Date06/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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