MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-220U
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The mentioned device was not returned to the service center for evaluation.Olympus followed up with the user facility to request the returned of the mentioned device and/or unused product from this lot and was informed that the product will not be returned.The cause of the reported event cannot be determine at this time.
Event or Problem Description
The service center was informed that during an unspecified procedure, that the patient's sample fell from the forceps into the scope¿s biopsy valve.The user facility¿s staff member removed the biopsy valve to retain the sample and was splashed in the eye with bioburden.The staff member was wearing protective eyewear when the incident occurred.Both the patient and the facility¿s staff member were blood panel tested.The staff member was placed on prophylactics as a precautionary measure, while test results were pending.The patient and staff member¿s blood test were negative for any cross contamination.In addition, the user facility reported that there has been a common observation when using this device that the physician has been unable to retain patient samples while transferring tissue samples from the scope to a collection receptacle.The user facility believes that there may be an issue with the grasp of the device.
Additional Manufacturer Narrative
This supplemental report is being submitted to report additional information.The content of this complaint was reviewed by the original equipment manufacturer (oem).The oem reported that the cause of the report event was not specifically identified, since the device did not return for the investigation.This is the first complaint of its kind for ¿resistance to withdraw the instrument during the procedure.¿ the oem reported that the most likely cause of the reported event is the instrument being quickly withdrew from the endoscope might have caused the blood and mucus scatter.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8735644
• Report Number: 2951238-2019-00975
• Device Sequence Number: 16787244
• Product Code: FCL
• UDI-Device Identifier: 04953170031076
• UDI-Public: 04953170031076
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-220U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: Required Intervention