MAUDE Adverse Event Report: COOK INC CUP BIOPSY FORCEPS

Model Number G15054

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Common name: endoscopic grasping/cutting instrument, non-powered; procode: ocz.(b)(6).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, during a ureteroscopy with biopsy in the ureter/collecting system that two cup biopsy forceps were used.Both devices broke in half at the cup portion.The broken piece from one of the devices was able to be retrieved, but the broken piece from the other device was not able to be retrieved and was left in the patient.This report will be for the device where they were able to retrieve the broken piece.Reference patient identifier (b)(6) for the device where they were unable to retrieve the broken piece.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Investigation ¿ evaluation: a user facility informed cook on 02/04/2020 of an incident involving a cup biopsy forceps.The device reportedly broke in half at the cup portion during a ureteroscopy and biopsy procedure on (b)(6) 2020.Further communication with the user facility clarified that two devices were used during the procedure and both broke in half at the cup portion.A second complaint was opened for the second device since the two devices did not have the same lot number (pr 292290).The procedure was not completed as result of the device issues.One of the two broken cups remained in the patient.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, quality control data, and specifications.One device was returned for investigation.Inspection of the returned device noted the device was returned with the handle in the closed position.The red cap was attached to the male luer lock adapter (mlla) on the handle.One of the cups of the device was broken and separated.The device broke at the base of the cup.Functional testing of the device noted that the handle does not actuate the remaining cup.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: important: excessive force could damage device.Store in a dark, cool, dry place.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have one cup broken off from the device.The cup was broken at the base and was returned.Two devices broke in the same manner during the same case, with the two devices being from different lots.This could indicate that there was an issue with the biopsy sample or another procedural issue that caused the breakage.The biopsy sample may have been dense enough to cause the breakage of the jaws before a sample could be obtained.There is not enough evidence to definitely conclude that the cause was procedure related, so the investigation conclusion is that the cause for the breakage could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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.

Event Description

No additional patient or event information has been received since the last report was submitted.

• Brand Name: CUP BIOPSY FORCEPS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9746152
• MDR Text Key: 200285601
• Report Number: 1820334-2020-00441
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00827002150546
• UDI-Public: (01)00827002150546(17)220319(10)9604447
• Combination Product (y/n): N
• PMA/PMN Number: K881399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: G15054
• Device Catalogue Number: 220130
• Device Lot Number: 9604447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RIGID URETEROSCOPE