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

Model Number	KD-610L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: health effect clinical code appropriate term: gastric stasis the event date was reported as the publication date of the literature.The literature article is attached for additional information.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
Olympus medical systems corp.(omsc) received a literature titled "characteristics of gastric stasis due to deformation after endoscopic submucosal dissection in the lower part of the stomach".This retrospective observational study aimed to evaluate the characteristics of gastric stasis due to deformation after endoscopic submucosal dissection (esd) in the lower part of the stomach, focusing on the differences between stenosis and deformation.A total of 41 patients were included.Deformation was observed in 12% (5/41) and stenosis was observed in the remaining 88% (36/41).The number of cases with angular dissection was significantly higher in the deformation group than in the non-deformation (stenosis) group (100% vs.17%; p < 0.001).Gastric stasis improved with additional treatment in all cases with deformation.Gastric stasis improved in two patients with endoscopic antralplasty (eap) and without surgery.In conclusion, all cases of gastric stasis due to deformation after gastric esd in the lower part of the stomach had a circumferential extent of the mucosal defect greater than 3/4.Type of adverse events/number of patients *gastric stasis after esd (41) *perforation(3) endoscopic balloon dilation (ebd) was performed using a non olympus controlled radial expansion balloon dilator.Three cases of perforation were associated with ebd.Ebd was performed in patients with gastric stasis during the follow-up period.However, repeated ebds did not improve gastric stasis, and eap eventually improved gastric stasis.This literature requires 2 reports with patient identifiers: 1.(b)(6) - kd-610l 2.(b)(6) -fd-412lr this report is for (b)(6).There was no documented olympus device malfunction in the literature.
Event or Problem Description
The author confirmed no olympus device caused or contributed to any patient adverse event.The customer believed the accident was caused by a technical issue and did not think the equipment or treatment was the cause.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received through follow up.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There is no evidence of an olympus device malfunction.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 17899811
• Report Number: 9614641-2023-01490
• Device Sequence Number: 3379814
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: KD-610L
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown