MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Per the initial reporter, it is unknown if the device will be returned.Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.Initial reporter: occupation = unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, the coating scraped off of an unspecified amplatz extra stiff wire.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report: as reported, during an unknown procedure, the coating scraped off of an unspecified amplatz extra stiff wire.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.Investigation - evaluation.Reviews of the documentation, drawing, manufacturer¿s instructions, quality control procedures, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the limited information available, a definitive cause for the failure mode could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9437336
• MDR Text Key: 176389907
• Report Number: 1820334-2019-03040
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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 Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1