MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number 635413

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

As reported, inside the unopened package of a standard fixed core wire guide, the customer found foreign matter which seemed to be a hair.The foreign matter was found while the package was in supply storage and did not have patient contact.

Manufacturer Narrative

Initial reporter name and address: (b)(6).Initial reporter occupation: quality coordinator.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, inside the unopened package of a standard fixed core wire guide, the customer found foreign matter which seemed to be a hair.The foreign matter was found while the package was in supply storage and did not have patient contact.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the device were conducted.The device was returned in unopened labelled packaging to cook for investigation.A hair was observed in the package near the black and red label.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.Due to the individual nature of inspecting packaged product, one nonconformance does not indicated additional nonconforming product in house or in field.A review of relevant manufacturing documents was conducted.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded the cause was a quality control deficiency.A review of manufacturing procedures found controls to be in place, the packaged products are visually inspected for foreign matter.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-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: 16656494
• MDR Text Key: 312699028
• Report Number: 1820334-2023-00355
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002145440
• UDI-Public: (01)10827002145440(17)250202(10)14514499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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
• Device Catalogue Number: 635413
• Device Lot Number: 14514499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1