MAUDE Adverse Event Report: COOK INC COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS

Model Number G05533

Device Problem Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Common name = device, biopsy, endomyocardial; (b)(4).(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during a biopsy, the cook flexible myocardial biopsy forceps did not close properly.Myocardial tissue was unable to be captured as a result.As no other forceps were available, the procedure was unable to be completed and was cancelled.Additional information regarding how the procedure was completed, event details, and patient outcome has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: narrative: per additional information received on 31jan2018, the myocardial biopsy was cancelled and was not rescheduled.Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, functional testing, and visual inspection of the returned device was conducted during the investigation.The complaint device was returned for investigation in used condition.Photos were provided for review.A functional test determined the handle does not open the forceps.A visual examination noted no physical issues with the forceps.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: b1, h1: upon further review of the complaint file, this complaint has been deemed non-reportable.Although the original procedure was cancelled and not rescheduled, there has been no report that the patient experienced any adverse effects resulting from the cancellation.Therefore, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.There is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.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: COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7194416
• MDR Text Key: 97346375
• Report Number: 1820334-2018-00149
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 00827002055339
• UDI-Public: (01)00827002055339(17)211108(10)7426370
• Combination Product (y/n): N
• PMA/PMN Number: K883723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G05533
• Device Catalogue Number: FBFE-5.2-120
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other