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

Model Number BML-110A-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

The subject bml-110a-1 was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the delivery date, it was found no irregularities.Based on the past similar cases, there is the possibility that the phenomenon of that the calculus cannot be crushed is attributed to the hardness and/or form of the calculus, and the perforation of the bile duct is attributed to the load of the crushing.The above device handling has warned in the instruction manual as follows.Do not use this lithotriptor bml-110a-1 for a calculus that is assumed impossible to be crushed by this lithotriptor.The basket wire etc.May break and part of this lithotriptor may remain in the body.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 4, ¿emergency treatment¿ may occur.Use this instrument by considering that it may lead to damaging the grasping forceps and that open surgery may have to take place.Do not force the distal end of the insertion portion against body cavity tissue.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.

Event Description

Olympus was informed that during an endoscopic mechanical lithotripsy, non-olympus (boston scientific) lithotriptor was used.Because the lithotriptor was unable to crush the calculus and could not be removed, the user tried to crush the calculus with the olympus emergency lithotriptor bml-110a-1.However the user could not crush the calculus and the user withdrew the bml-110a-1 unavoidably.Then the user observed the patient's affected area with the endoscope and found the perforation of the bile duct.No further information was provided.

• Brand Name: MECHANICAL LITHOTRIPTOR
• Type of Device: 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: 8810518
• MDR Text Key: 151708216
• Report Number: 8010047-2019-02612
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: BML-110A-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other