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

Model Number	G19111
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant devices: olympus flexible scope with 3.6fr working channel.Pma/510k #: exempt.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, manufacturing instructions, quality control data, and instructions for use.The customer returned one device.Returned packaging confirms lot number.Visual examination shows that the device was returned with the handle in the closed position and the basket formation partially open.The basket sheath and support sheath are severed at the base of mlla at the flare.Approximately 3 cm of coil is exposed between the points of separation.5 mm of basket sheath is protruding the proximal end of the support sheath, and the sheath has a bowed appearance.A review of the device history record revealed no non-conformances related to the reported failure.A review of complaint records for this lot revealed no other complaints.Cook also reviewed product labeling.The product ifu, t _ ntse_ rev.0, provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to have a basket that would not function correctly due to sheath damage.The yellow support tube and sheath were found to be separated at the handle, preventing the basket from fully opening or closing.All devices are inspected multiple times for damage and functionality during manufacturing and quality control checks.The devices are also packaged with the basket in the open position.The provided information states the device functioned properly when tested before use, but would not function once used inside the scope.It is likely the device was inadvertently damaged when used, or when being inserted into the scope.From the investigation of the returned device, it appears the sheath was bent at the handle, causing the sheath to become damaged and separate.The ifu provided with the device contains a precaution not to use excessive force to manipulate the device or damage may occur.Investigation conclusion: the cause is traced to the user.Unintended use error caused or contributed to this event.Per the quality engineering risk assessment, no additional risk mitigating activity is required.
Event or Problem Description
It is reported that during a percutaneous nephrolithotomy using a ncircle delta wire tipless stone extractor, the basket would not open.Prior to the procedure, the basket was pre-tested and confirmed to function properly.The physician then introduced the complaint device down the scope and as he attempted to open the basket, it would not open.The device was removed and another of the same device was used to continue the procedure with no further complications.The patient did not experience any adverse effects as a result of this alleged malfunction.The patient did not require any additional procedures as a result of this occurrence.

• Brand Name: NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8697510
• Report Number: 1820334-2019-01267
• Device Sequence Number: 11334256
• Product Code: FFL
• UDI-Device Identifier: 00827002191112
• UDI-Public: (01)00827002191112(17)211126(10)9333447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: G19111
• Device Catalogue Number: NTSED-024115-UDH-MB
• Device Lot Number: 9333447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR