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

Model Number BML-V442QR-30

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus and is currently pending evaluation.The cause of the reported event cannot be determined at this time.

Event Description

The user facility informed olympus that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the mechanical lithotriptor broke off and fell into the patient.The emergency handle was attached as instructed.The handle was turned twice and each time a clicking or ping noise was heard.The surgeon noted that all 3 lines were snapped at the rotating bar of the emergency handle.It was also noted that the stone remained uncrushed and basket remained wedged in the patient¿s common bile duct (cbd).The patient was administered additional anesthesia and two unsuccessful attempts were made to dilate the patient large enough to remove the basket utilizing dilating balloons.The surgeon then inserted a second basket, the stone was crushed and both the broken basket and stone were removed.There was minor bleeding observed.The patient¿s common bile duct sustained increased manipulation and increased dilation due to multiple attempts to retrieve basket.The patient's current condition is unknown.Additionally, it was reported that the basket had been stored on a supply cart and was inspected/ tested prior to use with no anomalies found.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.The reported complaint was confirmed.A visual inspection was performed on the received device and found the basket wire broken and detached.There was evidence of excessive force applied on the insertion portion of the device as kinks, buckles and the grey sheath covers were detached and exposing the coil sheath.The inspection also noted foreign material on the basket wire.Based on the evaluation findings, the cause of the reported phenomenon can be attributed to excessive force applied during use.The instruction manual warns users in the caution section ¿never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle¿.

Manufacturer Narrative

This supplemental report is being submitted to report additional information provided by the original equipment manufacturer (oem).The oem performed a review of the dhr and found no anomalies during the manufacturing of the subject device and lot number.A photographic evaluation was performed by the oem and it was determined that the most likely cause of the wires fracturing can be attributed to the load being larger than the wire strength when pressure was applied to crush a hard stone.This potential large load also likely caused the deformed basket.It is likely that the coating on the sheath was torn due to coming in contact with a sharp object.However, the evaluation could not conclusively identify how the coating was damaged.The instruction manual provides the user several warnings to prevent damage to the bml-v442qr-30: do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotripter.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 lithotripter bml-110a-1.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 this instrument by considering that it may lead to damage of 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.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6867588
• MDR Text Key: 86255412
• Report Number: 2951238-2017-00619
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

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 Catalogue Number: BML-V442QR-30
• Device Lot Number: 66K
• Other Device ID Number: 04953170218422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 01/11/2018
• Supplement Dates FDA Received: 10/03/2017; 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 166