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

Model Number	FG-V421PR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.However, omsc launched only products that had passed the inspection.The malfunction of the subject device concerning this case has not been reported, and there is no information indicating the relationship between this reported event and the subject device.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature title "comparison between endoscopic treatment and surgical drainage of the pancreatic duct in chronic pancreatitis".The literature reported the results of a study based on the endoscopic or surgical drainage of 51 patients with chronic pancreatitis between 2001 and 2010.During the study period, lithectomy were performed with the use of olympus retrieval basket, and basket impaction occurred in 1 patient.There is no description about the relationship between olympus product and adverse event.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 10299575
• Report Number: 8010047-2020-04628
• Device Sequence Number: 811916
• Product Code: LQR
• UDI-Device Identifier: 04953170244032
• UDI-Public: 04953170244032
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: No Information
• Device Model Number: FG-V421PR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/20/2020
• 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: Other