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

Catalog Number NTSE-015115

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k # ¿ exempt.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, upon delivery, the distributor found the hair-like substance was sealed in the unopened package.No patient involvement.

Manufacturer Narrative

Investigation ¿ evaluation.A distributor informed cook on 02/06/2020 of an incident involving a ncircle tipless stone extractor.The device reportedly was found to have foreign matter sealed inside the unopened package.The issue was discovered by the distributor and was not related to a procedure.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, quality control data, and specifications.One ncircle tipless stone extractor was returned for investigation.Visual exam noted a brown fiber was caught in the end seal of the packaging.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.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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 device was returned in an unopened pouch that contained a brown fiber in the unopened package.The likely cause is that the piece of f/m entered the pouch during the manufacturing process.Controls are in place to inspect for foreign matter both during the packaging operation and subsequent quality control inspection.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor 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 new patient or event information received since the last report was submitted.

Manufacturer Narrative

Investigation evaluation has been updated to include the information below, which was not included in our investigation evaluation on the previous mdr follow up report.Investigation evaluation: the cause for this complaint was a manufacturing issue.The operator that performed the sealing operation, and the quality inspector, were both retrained to the particulate inspection procedures applicable to their responsibilities.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 new patient or event information has been received since the last report was submitted.

• Brand Name: NCIRCLE TIPLESS 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: 9700796
• MDR Text Key: 199496112
• Report Number: 1820334-2020-00338
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)221119(10)10160683
• 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,Followup
• Report Date: 03/20/2020

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: No Information
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 10160683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/11/2020; 03/19/2020
• Supplement Dates FDA Received: 03/12/2020; 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1