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Catalog Number ECHO-HD-22-EBUS-O-C
Device Problems Material Perforation (2205); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #: k160229. Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event Description
The device was used for ebus-tbna. Olympus's endoscope bf-q290 was advanced to the hilar (lymph) nodes, then the target site was punctured with the needle of the complaint device, then the needle was fully retracted into the sheath and the device was retracted into the endoscope. When the physician switched the screen from ultrasound to endoscope screen, he noticed that a part of the screen turned black and confirmed that the optical fiber inside the endoscope broke off. Despite the event, the procedure was completed with no additional treatment since the planned procedure could be finished with the complaint device. There have been no adverse effects to the patient reported. Physician's comment: i kept using olympus's needle in the past. The endoscope (model number 290) broke once i used cook's device, so i think the cause of breakage of the endscope is associated with cook's needle device. Sales rep's comment: there was no problem in physician's way of use. The only difference from the past was that they used a procore needle for the first time in the 290 model endoscope. They usually used model 260 with procore devices before this procedure. The endoscope broke during the first case that the procore needle was used in a 290 model endoscope. I believe that the endoscope broke at that time by accident, but the physician blames that it occurred due to fault of the device. As far as i saw the returned device, i did not feel that the needle was broken or bent, so i do not think it is a procore's defect. However, please perform physical investigation of the returned device just in case. Request from the rep: please let me know if tere are other similar cases that an endoscope was damaged/ broken by a needle of ebus (ultra and procore) needle. Additional information: for all complaints, ask: answer (if any damages were confirmed prior to use)was the package damaged? n/a (if any damages were confirmed prior to use)how was the device stored? n/a are images of the device or procedure available? n/a, yes, no no if the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? n/a, handle end, patient end unknown "were any other defects (other than the complaint issue) observed on the device prior to return (e. G. Kink)? n/a, yes, no please specify if yes. " no. If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a, yes, no n/a. "if the device is a procore needle, is the device damage located at the notch / core trap? n/a, yes, no n/a if no, please specify where the damage is located: _____________________" n/a. Was gaining access to the target site difficult? n/a, yes, no no. Was the device used in a tortuous position? n/a, yes, no no. Was puncture of the target site difficult? n/a, yes, no no. A. Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc. ). Already stated in patient/event info tab. If the lungs, which lymph node was being targeted? e. G. 4r, 11r, 12l etc. Unknown please describe the size of the intended target site. Unknown if not with the device in question, how was the procedure performed and/or finished? already stated in patient/event info tab. Was the device damaged in packaging prior to removal? n/a, yes, no no. Was the device damaged on removal from packaging? n/a, yes, no no. Was force required to remove the device? n/a, yes, no no. Did the patient require any additional procedures as a result of this event? n/a, yes, no no. What intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day (same procedure) what is the scope manufacturer and model number that was used? bf-q290. Was resistance felt while inserting the device through the scope? n/a, yes, no no. Was the scope recently serviced / repaired? n/a, yes, no no. When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? other¿ already stated in patient/event info tab. Was the syringe used during the procedure, after the stylet was removed? n/a, yes, no yes. Was difficulty experienced while retracting the needle? n/a, yes, no no. Was it possible to fully retract the needle into the sheath before removing the device from the patient? n/a, yes, no yes. Was the endoscope in a flexed or twisted position at any time during the procedure? n/a,yes,no unknown. Was the stylet partially removed when advancing the needle into the target site? n/a,yes,no no. How many samples were obtained (passes completed) with this needle? 1 time "did any section of the device detach inside the patient? n/a, yes, no if yes, please specify:" no. Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? n/a, yes, no no. Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? n/a, yes, no no. When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? n/a, yes, no unknown. If an ebus procedure did the needle tip hit the cartilage rings of the trachea? unknown.
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Manufacturer (Section D)
o halloran road
Manufacturer (Section G)
o halloran road
national technology park
Manufacturer Contact
aisling hassett
o halloran road
national technology park
MDR Report Key12480359
MDR Text Key271660855
Report Number3001845648-2021-00680
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-22-EBUS-O-C
Device Lot NumberC1831058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/27/2021
Event Location Hospital
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial