MAUDE Adverse Event Report: COOK INC CAPTURA HELICAL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number G32727

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Customer name and address: phone: (b)(6).Occupation: quality specialist.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.

Event Description

As reported, during inspection by a distributor, the packaging of a captura helical stone extractor was found unsealed.The device did not make contact with a patient and was not used for any procedure.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: cook was informed of an incident involving a captura helical stone.The device reportedly was found to have a pouch that was not sealed.The issue was noted at a distributor and was not associated with any procedure or patient.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, specifications, and quality control data.Visual examination confirmed the device was received in unused condition.The bottom straight seal was open.The seal to the right of the notch was intact but wrinkled.The seal to the left of the notch was severely wrinkled and open.The package showed no signs of having been sealed on the left side.The white tyvek on the back was wrinkled, correlating with the clear poly wrinkle damage on the front of the package.Black debris was noted at the bottom of the package.The package and device sterility was compromised.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that additional nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.Based on the information available, cook has concluded that the cause of this issue was a manufacturing issue that the seal was not properly formed, and the defect was not caught upon subsequent inspection.The sealing operator was made aware of the issue and retrained in the sealing procedure.The quality inspector was no longer employed at cook and could not be retrained.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.

• Brand Name: CAPTURA HELICAL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10789396
• MDR Text Key: 214751233
• Report Number: 1820334-2020-02013
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002327276
• UDI-Public: (01)00827002327276(17)230312(10)13047350
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/12/2023
• Device Model Number: G32727
• Device Catalogue Number: CE-432115
• Device Lot Number: 13047350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1