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

Model Number SPL-PDBX376

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The legal manufacturer completed the investigation.The dhr for this device were not reviewed because no lot number was provided.Olympus ships products that are manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is undetermined.The following information is provided in the instructions for use, rev an: "when the ultrasound is activated, do not contact tissue with the tip or sides of the probe; tissue damage could result." (additional tip#9, page 23); "do not contact mucosal tissue with the tip of the activated probe as tissue damage may occur." (warning, page 23); and "the tip of the probe must be kept visible at all times when the transducer is activated." (caution, page ).

Event Description

The customer reported to an olympus representative, during a cystolitholapaxy with the shockpulse probe, the patient's bladder was perforated.The probe did not come in direct contact with the mucosal tissue.The probe did come in direct contact with the stone and pressure was applied to the stone with the probe.The size of the stone was 3-4 cm.There were not any procedural or anatomical challenges that could have caused or contributed to the bladder perforation.The power setting during the procedure was high.The vacuum pressure was 50 mmhg.Continuous irrigation was used with normal saline solution.No devices malfunctioned during the procedure.The probe was discarded after use and not available for return.The perforated bladder was treated with catheter placement post-procedure and will remain for two weeks.The patient is reported as 'fine'.

• 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
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12924931
• MDR Text Key: 285843495
• Report Number: 3003790304-2021-00182
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-PDBX376
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• 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
• Treatment: SPL-S, SERIAL UNKNOWN
• Patient Outcome(s): Required Intervention