MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK EVACUATOR; ELLIK BLADDER EVACUATOR

Model Number	000451
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: BARD® ELLIK EVACUATOR
• Common Device Name: 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 Key: 12224259
• Report Number: 1018233-2021-04480
• Device Sequence Number: 4255456
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGFQ4219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other