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

Model Number SPL-PDBX340

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been returned for evaluation, therefore we are unable to determine the root cause of the reported event.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

The customer reported to olympus during preparation for use, it was noted that the bottom of the device was broken off.There was no patient injury reported.

Manufacturer Narrative

Event description: customer found "bottom broke off during a case." the device was returned, the complaint was confirmed, the device was fractured near the braze joint at the proximal end.Failure in this manner is often a result of the application of excessive torque during use which causes wear against the endoscope at the proximal end of the instrument channel.The device ifu (spl-ifu rev am) warns on page 22, "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 the field performance of this device.A review of the device history record was completed and it was confirmed that there were no abnormalities, special adoptions, or variations in the manufacturing process.

• 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: 10312914
• MDR Text Key: 205175802
• Report Number: 3005975494-2020-00016
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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-PDBX340
• Device Lot Number: D1901149
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1