MAUDE Adverse Event Report: COOK INC STONEBREAKER PNEUMATIC LITHOTRIPTER

Catalog Number SBL-KIT1

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Common name: ffk lithotriptor, electro-hydraulic, product code: ffk.Pma/510k #: k062475 (b)(4).Sterilization date: (b)(6) 2009.Device is in transit to the manufacturer as it pertains to removal (b)(4) not related to this failure mode.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 during a percutaneous nephrolithotomy (pcnl) procedure after the ureteral catheterization when the patient should have been turned to prone position the nurse put the cartridge in the stonebreaker pneumatic lithotripter and found the cartridge was leaking next to the incising needle.They attempted to tighten the cartridge and tried a new cartridge, but couldn't get the device to work.The device was reported to not have had contact with the patient.The procedure was cancelled.Procedure has been postponed until (b)(6).It was reported that the patient had 3 extracorporeal shock wave lithotripsy (eswl) procedures in the past.No additional patient consequences were reported.

Manufacturer Narrative

Additional information: concomitant medical products.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, quality control data, and specifications.One stonebreaker box labeled rpn sbl-kit1 with serial number: (b)(4) was received.The device was returned without the probe cap.The stonebreaker device was returned without a probe cap.It was tested with a known good probe cap.No visible damage was observed however a severe leak was noted at location f (tube guide set screws or proximal tube launcher threads).Due to the severe leak, no further testing could be performed.The complaint was confirmed.A review of relevant manufacturing documents was conducted.The device was shipped out on 04sep2012 and the device has never been returned for servicing.A previously reported adverse event is associated with this device; reference mfr.Report#: 1820334-2017-04602.The device was requested from the user facility to perform a device analysis and investigation for this previous event but it was never returned to be evaluated.Review of the device history record did not observe any non-conformances that may have contributed to this incident.The stonebreaker device was returned and the co2 leak was confirmed.The leak is likely related to failure of the o-rings due to normal wear.The complaint is confirmed based on device analysis.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required at this time.This product was previously recalled and removed from the market.It should be noted the device was recalled but the customer never returned this recalled device.Recall z-1590-2018 through z-1596-2018, res 79731 initiated 31jan2018.Eu fsca 2018fa0004.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we 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

There has been no new information received since the last report was submitted.

• Brand Name: STONEBREAKER PNEUMATIC LITHOTRIPTER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7651960
• MDR Text Key: 112836498
• Report Number: 1820334-2018-01834
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SBL-KIT1
• Device Lot Number: 0900573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 82