MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V442QR-30

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the reported event cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during an endoscopic retrograde cholangiopancreatography (ercp)/emergency lithotripsy (stone extrusion) procedure using a single use mechanical lithotriptor v, two wires of the device were broken during attempted removal of a large stone and remained inside the patient.Prior to attempting the large stone removal, the device was "working fine" removing a few smaller stones.The stopper of the device was found inside the endoscope.The ercp took five hours.There is no report of duodenoscope malfunction.Right after the five hour ercp, the patient was taken for an unspecified emergent procedure to recover the device fragments.The outcome of the procedure/patient was good, there was no perforation of the papillae.After successful surgery and recovery of the basket remains, the patient was admitted to the intensive care unit.After another day, the patient was transferred to the normal unit.Later that night (into the next morning) after being transferred to the normal unit, the patient was found dead in his bed.The cause of death is unknown.No autopsy is to be performed.The physician does not believe that the single use mechanical lithotriptor caused or contributed to the patient's death.

Manufacturer Narrative

This report is being updated to provide investigation findings and corrected information.New information is reported in h6 and h10.Corrected data is reported in e4.Direct physical evaluation of the device could not be performed as the device was not returned to olympus.Review of the images provided by the customer revealed: ·the basket was visibly not broken.·the basket wire was not broken on the distal side.However, it is not possible to determine where the basket wire was broken.·the basket wire coming out of the endoscope after the coil sheath is removed is tangled.The device history record (dhr) for the reported lot was reviewed.The process inspection sheet, quality inspection and non-conforming product report were all carefully reviewed.There were no anomalies noted that could be related to the reported failure.The instructions for use shipped with the device provides the user with the following information related to the reported event: ·keep pliers or wire cutters so that you can cut the instrument if it is damaged.Also have the olympus bml-110a-1 lithotriptor ready.·do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor.The pipe or the basket wire may break and part of this instrument may remain in the body.·use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor bml-110a-1.·a lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place.·this instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected.·during lithotripsy, keep the portion from the coil sheath to the bml handle straight in line with the scope¿s biopsy valve, as much as possible.If not straight, the coil sheath may bend, calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.·do not rotate the bml handle knob abruptly.This instrument may break, and/or calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.The definitive cause of the reported event could not be conclusively determined.Based on previous investigation results, a likely cause of the basket wire breakage could be the following.1) due to issues possibly stemming from the size, shape, hardness or number of calculus, or from the amount of force applied when closing the basket wire, excessive force was required to execute the calculus lithotomy procedure causing the wire to break.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12911249
• MDR Text Key: 284145024
• Report Number: 8010047-2021-15352
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CLASS2-EXMPT
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Lot Number: 18K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/24/2021
• Supplement Dates FDA Received: 01/21/2022
• 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: TJF-Q190V, SN (B)(6)
• Patient Outcome(s): Other; Required Intervention; Death; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male