MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMS SWISS LITHOCLAST LITHOTRIPTER; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number UNK-M-69210

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on august 29, 2018 that a swiss lithoclast ultrasonic probe was used during procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the ultrasound probe broke off inside the patient and the broken pieces were retrieved with a grasper.Reportedly, the probe has been re-processed three times prior to the procedure.This probe can be re-processed up to five times.The procedure was completed with another lithoclast ultrasonic probe.There were no serious injury/adverse effect to patient as a result of the event.

• Brand Name: EMS SWISS LITHOCLAST LITHOTRIPTER
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ELECTRO MEDICAL SYSTEMS SA; ch. de la vuarpillière 31; ch-1260,; nyon, sz 1260 ; CH 1260
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7913806
• MDR Text Key: 121852656
• Report Number: 3005099803-2018-60527
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K012445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-M-69210
• Device Catalogue Number: 69210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other