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

Catalog Number ECHO-3-22

Device Problems Accessory Incompatible (1004); Nonstandard Device (1420); Retraction Problem (1536); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The customer provided a picture of the proximal end of the handle. The picture was a close up of the inside of the handle, where the stylet is inserted into the device. There appeared to be a piece of debris next to the hole for the stylet. The picture is inconclusive for retraction difficulties. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. 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 a biopsy procedure, the physician used a cook echotip ultra endoscopic ultrasound needle. The user completed the biopsy and intended to retract needle into sheath, but found the stylet cannot be retracted. There were two holes at stylet hub. The user changed to another of the same device to complete the procedure. 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

The device was received for evaluation. The investigation is in progress. A follow up report will be sent upon receipt of the supplier evaluation.

Event Description

During a biopsy procedure, the physician used a cook echotip ultra endoscopic ultrasound needle. The user completed the biopsy and intended to retract needle into sheath, but found the stylet cannot be retracted. There were two holes at stylet hub. The user changed to another of the same device to complete the procedure. On 16-aug-2020 the user confirmed that it was the needle portion of the device that did not retract. 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

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report. The label matches the product returned. The customer provided a picture of the proximal end of the handle. The picture was a close up of the inside of the handle, where the stylet is inserted into the device. There appeared to be a piece of debris next to the hole for the stylet. Our laboratory evaluation of the product said to be involved confirmed the report. During a visual inspection, it was observed that there is a second hole in the metal hub. The stylet was inserted in the side hole in the metal hub. During a function test with the stylet, the stylet would not pass through the center hole. Only the side hole would accept the stylet. The stylet can be fully advanced into the side hole. The needle adjuster was placed on "8" and the needle would advance and retract as expected when the handle was manipulated. During a function test, the device was placed down an olympus gf-uct160 (3. 2 mm channel endoscope) and the endoscope was placed in a curved position. The device advanced through the endoscope without resistance. The device was attached to the biopsy port. The needle would advance and retract when the handle was manipulated. The stylet was removed and then reinserted when the device was retroflexed. There was a lot of resistance encountered when advancing and retracting the stylet. The device was disassembled at the proximal end, to observe the metal hub and cannula more closely. The metal hub is attached to the needle cannula as intended. The side hole does pass through the metal hub and connect to the needle cannula. The center hole is missing the counter bore, which is located at the side hole instead. The device was sent back to the supplier for further evaluation. The supplier provided the following: "[the supplier] met to review the assembly with their personnel and their supplier. The root cause for the non-conformance is that the drill alignment was not concentric with the counter bore. The corrective action is to implement a gauge to check the concentricity of the counter bore and through hole. " the device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: the root cause for stylet retraction difficulties was due to the metal hub not being manufactured properly. The supplier does a 100% visual inspection to check that the cannula is fully seated into the counterbored hole. The supplier will be taking additional precautions by inspecting the hubs with a gauge to ensure concentricity of the counterbore hole with the cannula through hole. Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: the supplier implemented a corrective action to address the issue. A review of the complaint history was conducted and this represents an isolated occurrence. The likelihood of occurrence is considered rare. Further 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 a biopsy procedure, the physician used a cook echotip ultra endoscopic ultrasound needle. The user completed the biopsy and intended to retract needle into sheath, but found the stylet cannot be retracted. There were two holes at stylet hub. The user changed to another of the same device to complete the procedure. On (b)(6) 2020 the user confirmed that it was the needle portion of the device that did not retract. 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: 10350157
• Report Number: 1037905-2020-00303
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315218
• UDI-Public: (01)10827002315218(17)221227(10)W4302071
• Combination Product (y/n): N
• PMA/PMN Number: K171596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/27/2022
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4302071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 66 YR
• Patient Treatment(s): PENTAX EG-3870UTK ENDOSCOPE