MAUDE Adverse Event Report: COOK INC FASCIAL INCISING NEEDLE; FHR NEEDLE, GASTRO-UROLOGY

Model Number	G14519
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: customer occupation = urology coordinator.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.G4: pma/510(k) number = exempt.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 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.
Event or Problem Description
It was reported that three fascial incising needles from the same lot were opened and all had a white material on the needle.None of the devices made patient contact.A fourth fascial incising needle from another lot was opened and used for the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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
Summary of event: it was reported that three 'fascial incising needles' from the same lot were opened and all had a white material on the needle.None of the devices made patient contact.A fourth fascial incising needle from another lot was opened and used for the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found two non-conformances reported for lot 15223498.Cook has concluded the recorded non-conformances are unrelated to the reported failure mode.A complaint history database search showed no other related complaints associated with the complaint device lot 15223498.Due to the individual nature of cleaning the needles and inspecting the finished needles 3 non conformances does not indicate additional non conforming in house or in the field, also no other customers have reported complaints for the lot.Visual inspection of the returned complaint devices were also conducted.Two devices were returned in open packages with labels.Upon inspection there was a white appearance to the distal tip of the needles.Photos of the complaint devices were reviewed by the needles department who believe it was either soda or soap residue and the wash process in manufacturing should of removed this.Based upon the available information and results of the investigation, the complaint was confirmed based on results from the device failure analysis visual inspection.A review of manufacturing procedures found controls to be in place, the needles are washed after assembly and visually checked for discoloration in final inspection.A review of the device history record found no related anomalies and no other related complaints have been reported for the lot.Defect awareness training was completed.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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: FASCIAL INCISING NEEDLE
• Common Device Name: FHR NEEDLE, GASTRO-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16732440
• Report Number: 1820334-2023-00428
• Device Sequence Number: 17791378
• Product Code: FHR
• UDI-Device Identifier: 00827002145191
• UDI-Public: (01)00827002145191(17)260214(10)15223498
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2026
• Device Model Number: G14519
• Device Catalogue Number: 090070
• Device Lot Number: 15223498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown