MAUDE Adverse Event Report: ELECTRO MEDICAL SYSTEMS SA RIGID PNEUMATIC PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number 840-733

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  malfunction  

Event Description

Note: this report pertains to one of lithoclast rigid pneumatic probe devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-01181 for the first lithoclast rigid pneumatic probe, 3005099803-2023-01184 for the second lithoclast rigid pneumatic probe and 3005099803-2023-01186 for the third lithoclast rigid pneumatic probe.It was reported to boston scientific corporation that a lithoclast rigid pneumatic probe was used during a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2023.During the procedure, the physician noticed that three pneumatic probes have holes in their packages.A fourth lithoclast probe was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf device code a020504 captures the reportable event of holes in the packages.

• Brand Name: RIGID PNEUMATIC PROBE
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): ELECTRO MEDICAL SYSTEMS SA; ch. de la vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer (Section G): ELECTRO MEDICAL SYSTEMS SA; ch. de la vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16501422
• MDR Text Key: 311109832
• Report Number: 3005099803-2023-01186
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 840-733
• Device Catalogue Number: 840-733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1