MAUDE Adverse Event Report: OLYMPUS SURGICAL OLYMPUS SHOCKPULSE SE; LITHOTRIPTOR, ULTRASONIC

Catalog Number SPL-PD376

Device Problems Air Leak (1008); Temperature Problem (3022)

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

Event Date 06/27/2016

Event Type  malfunction  

Event Description

Approximately one hour into the procedure the surgeon began to complain of an increase in bubbles and warming of the hand piece.It was determined that the probe was broken.The broken probe was replaced with a new shock pulse probe.This improved the bubbles and the procedure was completed using the new probe.

• Brand Name: OLYMPUS SHOCKPULSE SE
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): OLYMPUS SURGICAL; 2400 ringwood avenue; san jose CA 95131
• MDR Report Key: 5764573
• MDR Text Key: 48631728
• Report Number: 5764573
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SPL-PD376
• Device Lot Number: W1605154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 123