MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PDBX376

Device Problem Break (1069)

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

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation; however, analysis of the device is not yet available and the cause of the reported event cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a bladder stones procedure, the probe broke inside the nephroscope device.The broken probes (2 parts) were retrieved and was replaced.There was no patient harm or injury reported due to the event.

Manufacturer Narrative

This supplemental report #1 updates the following section: g4, g7, h2, h3, h4, h6 and h10.The device was received for evaluation.The device was received in its original tyvek packaging with lot number d1901141.Visual inspection determined that the device is fractured 12.5 inches approximately from the distal tip.There were no other abnormalities observed.The device history record for this product has been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A review of risk documentation suggest there are several potential failure modes which may point to a probable cause.Fracture of a shockpulse probe may be a result of the user torquing or bending the probe leading to wear between the probe and the endoscope.The device ifu instructs/warns the user "the probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance.".

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 9820093
• MDR Text Key: 219135732
• Report Number: 2951238-2020-00372
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• 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: 04/29/2020

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
• Device Operator: Health Professional
• Device Model Number: SPL-PDBX376
• Device Lot Number: D1901141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1