MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-241K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
We received the following report.*when the endoscopy was performed, the biopsies led hemorrhage while the patient's mucous membrane was healthy with no anticoagulant treatment.One of the hemorrhagic biopsies resulted in an oval hematoma of 12mm.The patient was discharged once, then admitted to the emergency room in the evening of the day for (b)(6).The patient is still hospitalized.It is unclear if the biopsy forceps contributed to these events.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.The manufacturing record was reviewed and found no irregularities.The exact cause of the problem could not be conclusively identified, since the device was not retuned for the investigation.No abnormalities were found in the manufacturing record.Therefore, the phenomenon which was pointed out could not be confirmed.From the results of similar projects in the past, it is probable that the event you pointed out was caused by pressing the cup or needle too much against the tissue.The above device handling has warned in the instruction manual as follows.Do not force the distal end of the insertion portion against body cavity tissue.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.If you press the instrument¿s distal end too hard against the tissue in an attempt to take a sample more than needed, the risk of perforation increase.Do not take more than needed.Biopsy may cause bleeding.If you take a large sample or press the instrument¿s distal end against tissue excessively, the risk of bleeding will increase.Perform biopsy on minimum necessary spots only.
Additional Manufacturer Narrative
This supplemental report includes a correction to provide information that was inadvertently not included on the previous submission.The corrected fields are as follows: a1, d8, g2, h6, and h8.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10841641
• Report Number: 8010047-2020-08946
• Device Sequence Number: 3644235
• Product Code: EOQ
• UDI-Device Identifier: 04953170158087
• UDI-Public: 04953170158087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K950636
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2024

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
• Device Model Number: FB-241K
• Device Lot Number: 9YV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/17/2020; 04/28/2023; 05/03/2024
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 12/03/2020; 05/12/2023; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown