MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number	FD-411QR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that three days after a therapeutic rectal endoscopic submucosal dissection (esd) procedure had been performed, the patient condition deteriorated and when a large intestine examination was performed, it was discovered that blood had accumulated in the intestinal membrane of the large intestine (location unknown).It is unknown whether this was the cause of the deterioration of the patient's condition.No further information about additional treatment was provided but the patient's hospitalization period was extended.There was no report of a malfunction of any of the medical devices used during the procedure.There were no reports of further patient or user harm associated with this event.Patient identifier (b)(6) reports the electrosurgical generator used in this event.Patient identifier (b)(6) reports the single use electrosurgical knife used in this event.Patient identifier (b)(6) reports the evis lucera elite gastrointestinal videoscope used in this event.Patient identifier (b)(6) reports the single use electrosurgical hemostatic forceps used in this event.This medwatch report is for patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, although the device was not returned for an evaluation, no abnormalities were detected in the dhr.Therefore, it is determined that an abnormality of the device was not the cause of the reported event.However, since the surgeon used multiple devices to perform the procedure, it is not possible to determine which device caused the event.The exact cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿preparation, inspection, and operation: before use, prepare and inspect the instrument and a cord as instructed below.Should the slightest irregularity be suspected, do not use the instrument or accord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, mucous membrane damage or thermal injury and may result in more severe equipment damage.Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the insertion portion in the endoscopic field of view, do not use it.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not angulate the endoscope¿s bending section of the endoscope abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.When the instrument is used simultaneously with other accessories, these must be compatible with high-frequency current.Otherwise, this could cause patient injury, such as bleeding and/or thermal injury of tissue.It could also cause burns to the patient, operator or assistant.When the instrument is used simultaneously with other accessories compatible with high-frequency current, do not activate output while the accessory is in contact with body cavity tissue or with this instrument.This may cause bleeding or thermal injury to the non-target tissue.If you use the instrument several times during one procedure, confirm that there is no irregularity with its operation and appearance, each time you use it.Do not use the instrument if you detect any abnormality.The breakage of the distal end such as the operation wire¿s detachment could cause mucous membrane damages.¿ ¿inserting into the endoscope: when inserting the instrument into the endoscope, hold the slider firmly.Otherwise, the forceps may open and extend from the endoscope abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not force the instrument, if resistance to insertion is encountered.Reduce the angulation until the instrument passes smoothly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not advance or extend the instrument abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the endoscope and/or instrument.Do not press the instrument against the tissue while the forceps are closed or opened.This may cause patient injury such as perforation, massive bleeding, or tissue damage.¿ ¿cauterization/coagulation and hemostasis: be sure to check the output power of the electrosurgical unit before use.If the unit is used without prior output setting, perforation, bleeding or mucous membrane damage may result.Aspirate fluids such as mucus that adhere to the tube and body cavity tissue.Patient injury such as perforation, bleeding, mucous membrane damage and thermal injury of tissue could result if output is activated with these fluids adhering.Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding or mucous membrane damage.Do not angulate the bending section of the endoscope abruptly while activating output.Otherwise, perforation, bleeding, and/or mucous membrane damage may occur.Do not loop the a cord or bundle it with cables from other medical equipment (electrocardiograph, endoscopic video system, electrosurgical unit, etc.).High-frequency signals and spark discharge noise during cauterization may cause malfunctions in other medical equipment that could have an adverse effect on the patient.Another possibility is that output from the electrosurgical unit will be abnormal and could cause patient injury, such as perforation, bleeding or mucous membrane damage.When an irregularity is detected during use of this instrument, do not use the instrument anymore.Otherwise, perforation, bleeding or mucous membrane damage may result.When you cannot orient the forceps to the optimum direction, reduce the angulation of the endoscope and turn the handle until the forceps face to the optimum direction.Applying the current without orienting the forceps to the optimum direction may extend the activation time and cause perforation or bleeding.When applying the current, do not use an excessive amount of conduction.Doing so could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.Do not apply current while pressing the instrument against tissue while the forceps are closed or opened.This may cause patient injury such as perforation, massive bleeding, or tissue damage.Pulling the tissue when applying the current.This could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.Do not operate the endoscope quickly while grasping tissue.Otherwise, perforation, bleeding, or mucous membrane damage may result.Do not pull the slider with excessive force.Doing so could cause the manipulation wire to detach from the forceps.If you use the instrument with the wire detached, the wire may stick out and cause perforation, bleeding, or mucous membrane damage.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16440576
• Report Number: 9614641-2023-00270
• Device Sequence Number: 15266531
• Product Code: KNS
• UDI-Device Identifier: 04953170251535
• UDI-Public: 04953170251535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062517
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: FD-411QR
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H290T WITH SERIAL/LOT (B)(6).; KD-655Q WITH SERIAL/LOT UNKNOWN.; WA90003J WITH SERIAL/LOT (B)(6).
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male