MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE; GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE

Model Number	MAJ-1414
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, the stopper flew off when the patient coughed.The intended procedure was a diagnostic procedure.Procedure was completed with the same device.There was no patient harm or injury reported , no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to d4.D4: corrected the model number.The lot number is unknown.Customer confirmed the device was discarded.The legal manufacturer performed internal testing by combining the company's scope (bf-uc260fw sn: (b)(6) and the company's forceps plug (maj-1414, lot: 24k).The testing was completed by forcibly applying pressure from the tip of the scope to check if the forceps plug came off but could not reproduce the removal of the forceps plug.Based on the investigation results, the legal manufacturer has determined there is no potential for this malfunction of the biopsy valve flying off in the room to cause or contribute to an adverse event.H3 other text: device was discarded.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response and updates regarding event reported.Communication with the customer representative conveyed that the biopsy valve flew off in the room, not in patient and it was not inside the patient.No further information provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE
• 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: 14634766
• Report Number: 8010047-2022-09656
• Device Sequence Number: 5918347
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-1414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 10/05/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/05/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown