MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PDBX340

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to olympus however, photos of the subject device were provided.Investigation is in progress.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a stone removal from a bladder procedure, the distal end of the probe broke off and fell into the patient.The detached part of the probe was immediately retrieved using forceps and was able to be removed.The intended procedure was completed.There was no patient harm or injury reported due to the event.The patient was reported to be in good condition.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number, device evaluation (photos provided) and investigation conclusion.Two photos of the referenced device were provided, the physical device was discarded and not returned for evaluation.Review of the photos provided by the customer, confirmed the reported failure.The probe was fractured at proximal end.The lot number could not be confirmed.Due to no device return, a root cause of the reported complaint could not be determined.Fracture of the probe is often a result of user mishandling during use.The probe must be kept concentric to the endoscope's instrument channel while active to prevent the introduction of unnecessary torque on the probe.As stated on the ifu (instruction for use) the user manual states" 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.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10696775
• MDR Text Key: 211888625
• Report Number: 3011050570-2020-00110
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-PDBX340
• Device Lot Number: D1901187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1