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); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

E1: address- full address name of the facility is (b)(6).The subject device was received and evaluated at olympus service business center (sbc) singapore.Device evaluation found the reported issue was confirmed.Inspection noted that the probe was broken approximately 135 mm toward the rear end of the probe.In addition, corrosion on the side of rear end was observed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during a therapeutic percutaneous nephrolithotomy or pcnl procedure, while using the shockpulse-se on the patient, the device (lithotripsy probe, spl-pdbx340 lot: kr255276 ) was leaning on the nephroscopes¿ channel (wa33036a) broke inside the channel into two pieces.The broken piece was able to be retrieved.The broken probe was replaced and the intended procedure was completed using a similar device ( new piece of probe same model).There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's final investigation.Please see also updates in section d9, h3, h4 , h6 and h10.The device was received at legal manufacturer service repair center for evaluation.The device was received wrapped in bubble wrap, the model was confirmed to be spl-pdbx340 and the lot is kr255276.The device was removed from the bubble wrap and examined.The probe was confirmed to be broken.The probe was broke more toward the proximal end.The break was a clean break and there appears to be no fragmentation in the probe.The device was not used with a generator.There was rust found on the proximal end, this likely occurred after the device was sent for evaluation.The photos provided showed the device with no rusting and it in a bag with moisture.The device history records (dhr¿s) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Dhr review for this lot found no associated ncrs (nonconformance's), reported scrap or recorded process deviations relating to the reported failure.The customer stated that the probe was leaning on the nephroscopes channel when it broke.A possible cause of the break would be from that pressure from leaning.The ifu states (section 2.5 - 6.) "do not allow the probe to press against the scope during the procedure.Pressure on the probe may stall the transducer and heat the probe within the scope¿s working channel." this is likely why the probe was broken.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on response to follow up regarding the reported event.Communication via follow up, the following information were provided: stage of the procedure the probe broke occurred at the middle of the case.The breakage occurred in the nephroscope channel, outside the patient while the nephroscope was in the patient.No other information provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17296241
• MDR Text Key: 318779776
• Report Number: 3011050570-2023-00083
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

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: KR255276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/20/2023; 08/24/2023
• Supplement Dates FDA Received: 08/11/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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: NEPHROSCOPES (WA33036A).; SHOCKPULSE-SE (SPL-G).