MAUDE Adverse Event Report: COOK INC GREENE BIOPSY NEEDLE SET

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: device, percutaneous, biopsy.Procode: mjg.Occupation: purchasing.Pma/ 510(k) #: exempt.(b)(4).A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an unknown patient required a greene biopsy needle set for an unknown procedure.During the procedure, the needle left a "small shard" inside the patient.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
D11 ¿ concomitant medical products: rx meds: carefusion 22gx15cm act 2215 temno.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.- attachment: [pr286091_medwatch report #mw5091638.Pdf].
Event or Problem Description
Additional information received 27dec2019: the patient underwent a ct guided fine needle aspiration (fna) biopsy of the upper lobe of the left lung for an fdg avid nodule in that region.A post procedure chest x-ray showed 2 "tiny fragments at the medial border of the nodule.".
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 17jan2020.The access site of the needle was the left anterior lung and the operator stated the nodule pushed away from the needle during insertion of the needle.After the device was in place for approx.30 mins, the procedure was terminated and the biopsy was not completed.The fragments were not removed as of (b)(6) 2020, however a surgery is to be scheduled to remove the nodule and the fragments.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation-evaluation it was reported that a needle from a greene biopsy needle set fragmented and separated.The needle was used to access/perform a biopsy on an fluorodeoxyglucose (fdg) avid nodule in the upper lobe of the left anterior lung.The nodule pushed away from the needle so the needle had to be advanced multiple times.The fragment remains in the patient, but a surgery was scheduled to remove the nodule along with the fragments.The patient reportedly experienced no additional adverse effects due to this event.A review of the complaint history, device history record, drawing, quality control, and specifications of the device, were conducted during the investigation.The complaint device was not returned so a physical examination could not be performed.Since relevant dimensions could not be measured against specification, the device cannot be confirmed to be manufactured out of specification.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) was reviewed.The final lot and relevant subassembly lots revealed no nonconformance's.A database search revealed no other complaints at the time of investigation.Since there are no related nonconformance's or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.It was reported that the nodule pushed away from the needle multiple times.This may be due to multiple factors, such as a particularly hard, deep, and/or difficult to access nodule.The customer also reported that cartilage caused resistance during access, which may have contributed to the needle fragmenting.Based on the information provided, no returned product, and the results of the investigation, it was concluded that tortuous patient anatomy possibly contributed to this incident.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: GREENE BIOPSY NEEDLE SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9460482
• Report Number: 1820334-2019-03098
• Device Sequence Number: 11221168
• Product Code: MJG
• UDI-Device Identifier: 00827002033832
• UDI-Public: (01)00827002033832(17)240910(10)9875230
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2024
• Device Model Number: N/A
• Device Catalogue Number: DGBS-100
• Device Lot Number: 9875230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/27/2019; 01/17/2020; 03/09/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/06/2020; 02/13/2020; 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other