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

Model Number FG-V451P

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was 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 Description

During an endoscopic retrograde cholangiopancreatography, the subject device was used.The physician noticed that the basket wire became entangle and the basket could not be retracted when the subject device was withdrawn from the papilla.The intended procedure was completed without problems.There was no patient injury reported.On (b)(6) 2020, olympus medical systems corp.(omsc) found that the support wire was deformed, protruded and could not be retracted in the sheath.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The support wire was protruded from the distal end of the coil sheath.The loop part which was originally inside the coil sheath remained on the basket wire part.The support wire formed a loop and the basket could not be closed.When the support wire and the loop part were returned to their original positions, the basket wire was not entangled or deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the support wire was protruded since it was not withdrawn although the basket wire was withdrawn when the control grip was pulled.The support wire was not withdrawn since the sheath around the support wire or the support wire out of the sheath was angulated.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10540218
• MDR Text Key: 207294566
• Report Number: 8010047-2020-06575
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• PMA/PMN Number: K170811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V451P
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1