MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG, BIOPSY NEEDLE KIT

Catalog Number ECHO-3-22

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The stylet wire was returned with the device, however; the prepackaged syringe was not included.The device was returned with the needle adjuster thumbscrew unthreaded from the handle of the device.During a visual inspection, the insert that the needle adjuster thumbscrew threads into did not appear to have any anomalies.The thumbscrew was threaded back into the needle adjuster insert and was able to be locked into place.The needle adjuster was placed on an "8" and the sheath adjuster was placed on "5", and the handle was then manipulated.The needle would advance and retract as intended.When the needle was advanced outside the distal end of the sheath, the needle exhibited a significant bend.The needle was bent at 5 cm from the distal tip of the sheath.Additionally, a bend in the sheath was observed at 4.8 cm from the base of the handle.The sheath being bent in this area can occur if the handle of the device is not attached to the biopsy port.During a functional test, the device was placed down an olympus gf-uc160p (3.2 mm channel endoscope) and the endoscope was placed in a curved position.The device advanced through the scope without resistance.The device was attached to the biopsy port.The needle would advance and retract when the handle was manipulated as intended.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use include the following information to ensure proper use of the device: "needle must be fully retracted into sheath and thumbscrew on safety ring must be locked at 0 cm mark to hold needle in place prior to introduction, advancement or withdrawal of device.Failure to retract needle may result in damage to endoscope." "attach device to accessory channel port by rotating device handle until fittings are connected." "with ultrasound endoscope and device straight, adjust needle to desired length by loosening thumbscrew on safety ring, and advancing it until desired reference mark for needle advancement appears in the window of safety ring.Tighten thumbscrew to lock safety ring in place.Note: number in safety ring window indicates extension of needle in centimeters.Caution: during needle adjustment or extension, ensure device has been attached to accessory channel.Failure to attach device prior to needle adjustment or extension may result in damage to endoscope." bends and kinks in the sheath can occur if the device experiences excessive pressure.Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic ultrasonography (eus), the physician used a cook echotip ultra endoscopic ultrasound needle.The physician wanted t get a sample of tissue and cells of the pancreatic mass.He got some sample, two times [during the] case, but he was not satisfied.However, he could not penetrate.The sheath and the needle of the echo-3-22 was bent and the needle slipped.He had to finish with unsatisfactory [samples].The additional information provided with the complaint form indicates that the bend in the needle was at the patient end of the device (subject of this report).A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This report is being sent to correct section b4 date of this report, f8 date of this report, and g4 date received by manufacturer from 06/05/2018 to 06/01/2018.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The stylet wire was returned with the device, however; the prepackaged syringe was not included.The device was returned with the needle adjuster thumbscrew unthreaded from the handle of the device.During a visual inspection, the insert that the needle adjuster thumbscrew threads into did not appear to have any anomalies.The thumbscrew was threaded back into the needle adjuster insert and was able to be locked into place.The needle adjuster was placed on an "8" and the sheath adjuster was placed on "5", and the handle was then manipulated.The needle would advance and retract as intended.When the needle was advanced outside the distal end of the sheath, the needle exhibited a significant bend.The needle was bent at 5 cm from the distal tip of the sheath.Additionally, a bend in the sheath was observed at 4.8 cm from the base of the handle.The sheath being bent in this area can occur if the handle of the device is not attached to the biopsy port.During a functional test, the device was placed down an olympus gf-uc160p (3.2 mm channel endoscope) and the endoscope was placed in a curved position.The device advanced through the scope without resistance.The device was attached to the biopsy port.The needle would advance and retract when the handle was manipulated as intended.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use include the following information to ensure proper use of the device: "needle must be fully retracted into sheath and thumbscrew on safety ring must be locked at 0 cm mark to hold needle in place prior to introduction, advancement or withdrawal of device.Failure to retract needle may result in damage to endoscope." "attach device to accessory channel port by rotating device handle until fittings are connected." "with ultrasound endoscope and device straight, adjust needle to desired length by loosening thumbscrew on safety ring, and advancing it until desired reference mark for needle advancement appears in the window of safety ring.Tighten thumbscrew to lock safety ring in place.Note: number in safety ring window indicates extension of needle in centimeters.Caution: during needle adjustment or extension, ensure device has been attached to accessory channel.Failure to attach device prior to needle adjustment or extension may result in damage to endoscope." bends and kinks in the sheath can occur if the device experiences excessive pressure.Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic ultrasonography (eus), the physician used a cook echotip ultra endoscopic ultrasound needle.The physician wanted t get a sample of tissue and cells of the pancreatic mass.He got some sample, two times [during the] case, but he was not satisfied.However, he could not penetrate.The sheath and the needle of the echo-3-22 was bent and the needle slipped.He had to finish with unsatisfactory [samples].The additional information provided with the complaint form indicates that the bend in the needle was at the patient end of the device (subject of this report).A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7649965
• MDR Text Key: 113196750
• Report Number: 1037905-2018-00277
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K171596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GF-UCT260 ENDOSCOPE