MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RETRIEVAL BASKET V

Model Number	FG-V421PR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During a removal of calculus, the subject device was used.In the procedure, the basket wire was incarcerated.The physician tried to crush the calculus with the emergency handle, but the basket wire broke.The patient was sent to open surgery and the fragment was removed.No further information was provided.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device 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.The manufacturing record in the past one-year from the event date was reviewed and found no irregularities.Based on the past similar cases, it was possible that the calculus could not be passed through the bile duct due to one of the following factors.The calculus was larger than the opening papilla.The bile duct was narrow.The customer has grabbed a lot of calculi with basket at once.The basket was deformed while repeating retrieving.The instruction manual of the device has already warned as follows; do not use this instrument if the target calculus is found to be impossible to retrieve through preoperative diagnosis, interoperative contrast enhancing, or after papillotomy/papillary dilation.Do not use this instrument to grasp multiple calculi at one time.Doing so may make it impossible to remove the basket (with calculi engaged) from the patient.If retrieval can no longer be performed, follow the procedures described in section10.8, ¿emergency treatment¿.Do not try to withdraw the instrument forcibly.This could result in perforation, bleeding, or mucous membrane damage.When the basket does not open and/or close smoothly, do not apply force but move the forceps elevator, set the endoscope¿s bending angle back, or move the position of the basket until the basket opens and closes smoothly.If the action of opening/closing the basket is forced, the tube may stretch and the resistance in operating the handle may increase.Also, the calculus may not be retrieved, and/or the basket with calculus engaged may become impacted in the body.*repetition of calculus retrieval will deform and/or deteriorate this instrument.Deformation and/or deterioration may make it difficult to retrieve a calculus or could cause the basket with calculus engaged to become impacted in the body.If calculus retrieval needs to be repeated in a single case, be sure to inspect the action and the appearance before each retrieval.Stop use if any abnormality (e.G., basket wire is cut or worn, tube sheath is bent, etc.) is detected during the inspection.
Additional Manufacturer Narrative
This supplemental report is submitting to correct "device product code".

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Common Device Name: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7929087
• Report Number: 8010047-2018-01915
• Device Sequence Number: 1474213
• Product Code: LQR
• UDI-Device Identifier: 04953170244032
• UDI-Public: 04953170244032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: FG-V421PR
• Device Lot Number: .
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/26/2018; 02/20/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/06/2018; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention