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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK EVACUATOR; ELLIK BLADDER EVACUATOR
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK EVACUATOR; ELLIK BLADDER EVACUATOR Back to Search Results
Model Number 000451
Device Problems Off-Label Use (1494); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the user removed the tubing of ellik evacuator by pulling it off because it was too flimsy.Due to this issue, the surgeon complained they attached their silicone ends, and also they needed to attach them for the olympus adaptor to fit the instrument.They had to give it a bit of tug to remove it, but they had been doing this for the last few years without any issue.
 
Event Description
It was reported that the user removed the tubing of ellik evacuator by pulling it off because it was too flimsy.Due to this issue, the surgeon complained they attached their silicone ends, and also they needed to attach them for the olympus adaptor to fit the instrument.They had to give it a bit of tug to remove it, but they had been doing this for the last few years without any issue.
 
Manufacturer Narrative
The reported event was confirmed use related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product had caused the reported failure.Visual evaluation of the photo sample noted one opened (without original packaging), ellik evacuator.Visual inspection of the sample noted the yellow latex tube was not present in the attached photo.It is unknown if the yellow latex tube was too flimsy, because the sample could not be tested.Further, the complainant reported attaching their own "silicone end", and it was a bit too difficult to remove.The "silicone end" and the adapter was not present in the photo attached.Based on the reported event, the "silicone end" is considered off-label use, and therefore it is use related.The root cause is determined to be off-label use.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "for use with resectoscope sheath manufactured by r.Wolf and k.Storz.A separate adapter is enclosed for use with resectoscope sheath manufactured by acmi".The actual/suspected device was inspected.
 
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Brand Name
BARD® ELLIK EVACUATOR
Type of Device
ELLIK BLADDER EVACUATOR
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12224259
MDR Text Key263368674
Report Number1018233-2021-04480
Device Sequence Number1
Product Code KQT
UDI-Device Identifier00801741080814
UDI-Public(01)00801741080814
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial
Report Date 02/18/2022
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
Device Operator Health Professional
Device Model Number000451
Device Catalogue Number000451
Device Lot NumberNGFQ4219
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/29/2021
Initial Date FDA Received07/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2021
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) Other;
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