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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The manufacturing history of the subject device was reviewed, with no irregularities noted.Therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information or the device is received a later time, this report will be supplemented.

Event Description

During ercp, the physician tried to crush calculus, the basket wire of the subject device was broken and the procedure was moved to emergency lithotripsy.The sheath was cut with wire-cutters as close to the handle as possible, and scope was withdrawn.Removing the sheath of the subject device was attempted but failed.A part of the subject device remained stuck in the patient.The physician attached an emergency lithotriptor (competitors' products) to the remaining portion of the sheath but the sheath was not long enough to complete this.The patient was sent to an operating room and the remained portion of the subject device was retrieved.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the evaluation of the returned device.As a result of evaluating the subject device on february 28, 2017, the basket wire and the coil sheath were cut off with a tool.In addition, the basket and the coil sheath were deformed.One side of the end surface of the operating wires was a smooth surface cut with a tool and the other side was in a condition where the wires were pressed and crushed.Further, there were nothing abnormal found in the outer diameters of each operating wire and the basket wire.From manufacturing record of the same lot for the subject device, nothing abnormal related to the reported event was detected on the following items.(1)outer diameter of the basket wire; (2)deformation of the basket wire; (3)outer diameter of the operating wire; (4)overflown length of the brazing filler at the brazed part; (5)outer diameter of the brazing part; (6)outer appearance of the brazing part.Based on the similar cases in the past, it is surmised that during crushing the calculus, a large load more than durability strength of the product was applied due to the factors, such as size, hardness, and shape of the calculus, which caused the buckling of the coil sheath and the breakage at the junction between the operation pipe and the basket wire.The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it also describes what to do if the lithotriptor cannot crush the calculus.Warning: (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.(2)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 ithotripsy 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, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6321187
• MDR Text Key: 67077303
• Report Number: 8010047-2017-00150
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup

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: 64K
• Other Device ID Number: 04953170218422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• 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): Hospitalization; Required Intervention