• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-HD-22-EBUS-O-C
Device Problems Break (1069); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The following additional information has been requested but not yet provided: ¿in what way did the doctor feel 'it was a defective tip', can the occurrence of the event be clarified in detail. ¿ it was originally indicated that the device involved in this complaint was being returned to cook (b)(4) for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated. As the device has not yet been returned for evaluation, the cause of this complaint could not be conclusively determined. The customer complaint is considered to be confirmed based on customer testimony only due to lack of information. Prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at (b)(4). A review of the manufacturing records for echo-hd-22-ebus-o-c devices of lot number c1270899 did not reveal any discrepancies which could have contributed to this complaint issue. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
As reported to customer relations: "the doctor felt it was a defective tip. ".
 
Manufacturer Narrative
Pma/ 510k
=
k160229. (b)(4). On evaluation of the returned device, it was noted that the needle was out of the sheath on return. There was no damage noted to the tip, this was also inspected under the microscope and no damage could be seen. The needle advanced and retracted fine. The customer complaint could not be confirmed as there was no issue found with the returned device. Prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at (b)(4). A review of the manufacturing records for echo-hd-22-ebus-o-c devices of lot number c1270899 did not reveal any discrepancies which could have contributed to this complaint issue. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Follow up required based on device evaluation and re-categorisation of this complaint from a needle breakage to a possible non retraction complaint. As reported to customer relations: "the doctor felt it was a defective tip. " based on the laboratory evaluation received on the 20-jan-2017: it was noted that the needle was out of the sheath on return. There was "no damage to tip" and device "advances/retracts fine". There was "no defect" noted during the evaluation.
 
Manufacturer Narrative
Pma/ 510k
=
k160229. (b)(4). On evaluation of the returned device, it was noted that the needle was out of the sheath on return. There was no damage noted to the tip, this was also inspected under the microscope and no damage could be seen. The needle advanced and retracted fine. The following information was provided by r&d in relation to the exposed needle on return: "in this complaint the user did not fully retract the needle before returning the device. From the photographs in the complaint investigation you can see the locking ring was set to 1cm and this is the approximate distance the needle was protruding from the sheath tip therefore possibly suggesting the user did not return the locking ring to the 0 position giving the needle the opportunity (even if it was fully retracted to 0cm) to advance to the 1cm mark during transportation. Also possibly suggesting the user could possibly have thought the 1cm position was the fully retracted position not checking the sheath tip to ensure the needle tip was fully protected by the sheath tip. The customer complaint could not be confirmed as there was no issue found with the returned device. Prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at (b)(4). A review of the manufacturing records for echo-hd-22-ebus-o-c devices of lot number c1270899 did not reveal any discrepancies which could have contributed to this complaint issue. Complaints of this nature will continue to be monitored for potential emerging trends. Emerging trends.
 
Event Description
This follow up report is being submitted to cancel the initial report. Additional information received on the 16-feb-2017 from r&d. Reference statement from r&d in the investigations section that offers causes for the needle being received un-retracted that do not include a "non retraction" issue. This event has been re-assessed as no longer meeting the reporting criteria of an fda mdr malfunction report. As reported to customer relations: "the doctor felt it was a defective tip. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer Contact
tracy o'sullivan
o halloran road
national technology park
limerick 
061334440
MDR Report Key6245177
MDR Text Key64613062
Report Number3001845648-2017-00010
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-22-EBUS-O-C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/15/2016
Event Location Hospital
Date Manufacturer Received12/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-