MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MB-358 SEMI-DISPO. BIOPSY VALVE (10PCS)

Model Number MB-358

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The facility uses a third party repair entity to repair and service the scope.The root cause of the reported event cannot be determined.The instruction manual warns users: ¿confirm that the slit and hole on the biopsy valve have no splits, cracks, deformations, discoloration, or other damage.The biopsy valve is a consumable that should be inspected as follows before each use.Replace it with a new one if any irregularity is observed during the inspection.¿.

Event Description

Olympus was informed that during an unspecified procedure, a rubber piece from the scope fell into the patient.The surgical staff believed this fragment to be the biopsy valve.The device fragment was retrieved from the patient using forceps.The intended procedure was completed using the same device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from knw to fds.

• Brand Name: MB-358 SEMI-DISPO. BIOPSY VALVE (10PCS)
• Type of Device: BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5805368
• MDR Text Key: 50720434
• Report Number: 2951238-2016-00604
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MB-358
• Device Catalogue Number: MB-358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1