MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE NEEDLE; INJECTOR FOR NM-101C-0427

Model Number MAJ-656

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.It was discarded by the facility.The device history record for this could not be assessed as the lot number was not provided.Olympus does not ship any devices that do not meet all the design and safety specifications.The instructions for use (ifu) shipped with this device provides the user the following information regarding the reported event: do not bring the needle in contact with or allow it to pierce non-target tissue.This may result in infection control risk, operator or patient injury.When using this instrument, always wear appropriate personal protective equipment.Otherwise, blood, mucous and other potentially infectious material from the patient could pose an infection control risk.Appropriate personal protective equipment may include: eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.Do not bring the needle after using in contact with or allow it to pierce your skin.Blood, mucous and other potentially infectious material from the patient could pose an infection control risk.Do not insert the instrument into the endoscope if the needle is not completely retracted into the sheath.The distal end of the insertion portion may extend from the distal end of the endoscope abruptly.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It could also damage the endoscope and/or instrument.After use, dispose of the needle section in an appropriate manner.If the needle section is not properly disposed of, it could pose an infection control risk or operator injury can result.The needle section is a single use, disposable item.Do not reuse or attempt to sterilize.Reusing the needle section could pose an infection control risk, cause tissue irritation or malfunction.Conclusion: since there have been no reports of device malfunction, it can be inferred that the mishandling the device by user might have contributed to the reported event.It is possible that the user came into contact with the needle accidentally causing the reported event.This event has been reported by the importer on mdr# (b)(4).

Event Description

It is reported during a bladder botox procedure using a disposable needle, the nurse experienced a needle stick when withdrawing the needle from sheath.Both the patient and nurse required blood draws to rule out cross infection between them.The lab results showed there was no disease transmission between the two.It is reported there was not malfunction of the needle.The needle was discarded by the facility.

• Brand Name: DISPOSABLE NEEDLE
• Type of Device: INJECTOR FOR NM-101C-0427
• 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: 12160773
• MDR Text Key: 261361723
• Report Number: 8010047-2021-08823
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170062469
• UDI-Public: 04953170062469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993041
• 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
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-656
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other