MAUDE Adverse Event Report: COOK INC KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE; MIJ NEEDLE, TUMOR LOCALIZATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, during placement of the hook wire portion of the kopans modified breast lesion localization needle, part of the external wire reportedly snapped off in the radiologist's hands as the device was being secured to the patient's chest with a dressing.To secure the device, it is reportedly common practice to bend the external wire a little.The patient underwent a scheduled procedure on the same day, during which the patient's lump was resected and the complaint product was to be retrieved; it was then discovered during this procedure that the a section of wire had also fractured just under the patient's skin as well.The operator removed both the hook wire and the discovered wire fragment from the patient.All fragments of the wire were ultimately recovered.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the hook wire was separated into two pieces.The hook itself is not intact on either piece.The first piece was bent 90 degrees approximately 6.5 cm from the separation.The second piece was bent in several locations.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other complaints reported for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
• Common Device Name: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6996304
• Report Number: 1820334-2017-03791
• Device Sequence Number: 1299413
• Product Code: MIJ
• UDI-Device Identifier: 00827002025868
• UDI-Public: (01)00827002025868(17)220601(10)7957481
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DKBL-20-5.0-A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention