MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Evaluation determined that the connector was broken, and the suction port was damaged.The device was found to be not repairable.The spl-t is a non-repairable model.The customer was informed that repairs on the model cannot be performed and will need to return unrepaired.Based on device evaluation findings, the root cause of the issue is undetermined however, the likely cause attributed to mishandling and or maintenance issue.

Event Description

It was reported that the lithotripsy capital ltp3201 cable was found pulled out of the transducer housing and was determined to be loose.According to the reporter, the issue was observed during reprocessing.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr), complaint history reports.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on review of complaint history there is no indication of systemic failure related to the reported phenomenon a definitive root cause could not be determined.The damage to the irrigation port indicates heavy use.It is likely possible that the connector becomes damaged over time if the cord was repeatedly pulled from the receptacle with significant force without using the finger hold.Sterilization or reprocessing agents may have also contributed to the degradation of adhesive used in the assembly of the plug.Per the device ifu, the transducer is validated for 100 reuses and is not validated for high-level disinfection per ifu for reprocessing instructions.It is unknown how many uses this unit has endured.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10247292
• MDR Text Key: 219549918
• Report Number: 3011050570-2020-00016
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1