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

Catalog Number NTSE-030115-UDH

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: supply coordinator 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, while putting an ncircle tipless stone extractor in their inventory, a piece of grass or natural debris was found inside the package.The packaging has not been opened.No patient involvement.

Manufacturer Narrative

Event summary: it was reported, while putting an ncircle tipless stone extractor in their inventory, a piece of grass or natural debris was found by a distributor inside the package.The packaging has not been opened.There was no patient involvement.Investigation - evaluation.Reviews of the complaint history, device history record, manufacturing instructions, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.One ncircle tipless stone extractor was returned for investigation.Visual exam confirmed brown debris measuring 3cm in length within the sealed package.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions, specifications, or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that the foreign matter observed in the device packaging was likely introduced during the manufacturing process.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 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: 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: 10455220
• MDR Text Key: 209613722
• Report Number: 1820334-2020-01565
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002176277
• UDI-Public: (01)10827002176277(17)230316(10)13054047
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/16/2023
• Device Catalogue Number: NTSE-030115-UDH
• Device Lot Number: 13054047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1