MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, this report will be supplemented when new and relevant information becomes available.
Event or Problem Description
Olympus reviewed the following literature titled "esd improvements in d-lecs with esd".Literature summary background and purpose endoscopic submucosal dissection (esd) for superficial non-papillary duodenal tumor epithelial tumors has become a safer and more effective procedure than conventional esd using the water pressure method and string clip suturing method reported by yazaku.On the other hand, lparoscopic endoscopic cooperative surgery for non-ampullary superficial duodenal neoplasms (d-lecs) is broadly divided into full-thickness resection (with ftr) and with esd (reinforcement after esd), and at our hospital, d-lecs with esd is applied to duodenal adenomas and early duodenal cancers.So clips were used at that time, and the purpose was to present the ingenuity at that time.Subjects and methods the subjects were 78 patients who visited our hospital from (b)(6 2001 to (b)(6) 2022 and were diagnosed with non-ampullary duodenal adenoma (snada) by biopsy.After consultation with the hospital ethics committee, we started d-lecs with ftr in february 2012, and introduced d-lecs with esd in (b)(6) 2019.Currently, a laparoscope is inserted after d-lecs with esd, and the knife used is a 1.5mm dual knife.After the lesion was excised, the patient was placed in a supine position and the sutured area was sutured.Results and discussion a total of 31 cases were treated, of which 11 were in the d-lecs group, and cases that did not meet the in-hospital treatment standards were followed up.There were 7 cases of d-lecs with ftr and 4 cases of d-lecs with esd.There were no significant differences in the average age, gender, tumor diameter, lesion localization, tumor length, or r0 resection rate.Among d-lecs with esd cases, 3 cases used so clips and 1 case did not use so clips.A large perforation was observed in the unused root.When using the so clip, we take into account the fragility of the duodenal mucosa, and (1) place the clip on the mucosal side of the non-lesioned area.Therefore, the surface of the incised mucosa and the peeled surface are not sandwiched between the clips.(2) use a highly viscous local fluid just before applying the clip to avoid grasping the muscle layer.At our hospital, we use riftal k.(3) because the lumen is narrow, it may not be possible to obtain a sufficient field of view even when the contralateral mucosa is pulled.At that time, actually apply tension and decide which parts to pull towards the mouth and anus.(4) if it is difficult to obtain a sufficient field of view, an entrance is created to remove the submucosal layer.If esd is used alone, it is possible to fill the gastrointestinal tract with physiological saline, but when inserting a laparoscope after performing esd, it is expected that the field of view on the laparoscopic side must be secured thoroughly.Therefore, we believe that it is desirable to secure the field of view using so clips for d-lecs with esd.Conclusion when performing d-lecs with esd, the combined use of so clips seems to help perform esd relatively safely and while securing the field of view.Type of adverse events/number of patients perforation (1).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's updated investigation and to provide additional information received through follow up (b5).Based on the results of the updated investigation, there is no change to the previously reported investigation results.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 18865755
• Report Number: 9614641-2024-00619
• Device Sequence Number: 20876165
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: KD-655Q
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 06/05/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/06/2024
• 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: Other
• Patient Sex: Unknown