MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET; SKYLITE BASKET

Model Number 041900

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the skylite basket had an unspecified malfunction.Per additional information received from the complainant via email on jul 29 2019 the hand piece of the device was broken.

Event Description

It was reported that the skylite basket had an unspecified malfunction.Per additional information received from the complainant via email on jul 29 2019 the hand piece of the device was broken.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the sample noted one opened (without original packaging) skylite nitinol stone basket.It was noted that the basket slide was detached from the stone basket handle.The assembly was not conforming to regulations and was out of specification.After reassembling the basket slide back onto the stone basket, the device functioned properly.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be "lack of epoxy / adhesive / cure time." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: " "precautions: before using, inspect for any breach of packaging to ensure sterility of product.Do not use if breach in sterile barrier is obvious or suspected.Do not allow the device to come in contact with any electrified instruments or laser.Kinks in the sheath will hinder the mechanical operation of the basket, may affect insertion or withdrawal of the basket and has the potential to damage the endoscope¿s instrument channel.Do not allow the device to be directly fired upon by any lithotripsy devices.To do so may result in damage to the device and could result in patient injury.Potential complications that may result from the use of a basket in an endoscopic urological procedure include, but are not limited to: ¿ perforation ¿ evulsion ¿ edema ¿ entrapment ¿ laceration ¿ basket inversion ¿ hemorrhage ¿ inability to disengage from irretrievable object".

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
• Type of Device: SKYLITE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8890162
• MDR Text Key: 184697727
• Report Number: 1018233-2019-04696
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741111518
• UDI-Public: (01)00801741111518
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGDP1596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1