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

Model Number	KD-655L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect - clinical code 4581 is used to code for superficial muscular layer thermal injury and entrapment of a small bowel (sb) loop into the otsc.The suspect device has not been returned to olympus.Additional information has been requested but no information has been received at this time.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "small bowel entrapment after otsc deployment for endoscopic closure of a colonic iatrogenic perforation".Literature summary: an 80 year old man was admitted for removal of a 35 mm lateral spreading tumor (lst) non-granular flat elevated type in the sigmoid colon.An endoscopic submucosal dissection procedure was performed.During the procedure, after coagulation of a submucosal vessel (soft coagulation, effect 4, 80 w), a 6 mm superficial muscular layer thermal injury occurred.Despite carbon dioxide insufflation, the muscle fibers dissected and the injury worsened (fig.1a,b).Thus, a trough-the-scope (tts) clip was placed to close the defect (fig.1c).It was decided to complete the resection using the piecemeal underwater endoscopic mucosal resection (emr) technique.Complete resection was achieved.After emr, despite the previous placement of the tts clip, mucosal defect inspection revealed exposure of fat underneath the muscular layer, suggestive of a transmural defect (fig.1d).The clip was removed with a foreign body forceps, confirming a 10 mm perforation (fig.2a).A 14/6t over-the-scope clip (otsc, ovesco®, tübingen, germany) was placed, using the suction method.Although complete closure of the defect was achieved, entrapment of a small bowel (sb) loop into the otsc was noticed (fig.2b).Computed tomography (ct) confirmed the presence of the sb wall captured within the otsc without obstruction of the lumen (fig.2c).After surgical team evaluation, the patient underwent surgery.Despite the absence of ischemia, the sb wall was irreversibly damaged due to transmural perforation caused by the otsc jaws (fig.2d).Patient underwent segmental sb resection and sigmoidectomy without further complications.Thus, the report concluded that otsc is a safe and effective treatment for the endoscopic closure of colorectal transmural defects.Type of adverse events: superficial muscular layer thermal injury.Perforation.Entrapment of a small bowel (sb) loop into the otsc.This literature article requires 2 reports.The related patient identifiers are as follows: 1.(b)(6) - gif-hq190.2.(b)(6) - kd-655l.This medwatch report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
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 event 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 received from the customer as reflected on b5.
Event or Problem Description
Olympus received further information from the customer confirming that there was no malfunction of the olympus device, and that the olympus device did not cause or contribute to any of the adverse events described in the literature.

• 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: 17941165
• Report Number: 9614641-2023-01533
• Device Sequence Number: 6416390
• Product Code: KNS
• UDI-Device Identifier: 04953170405624
• UDI-Public: 04953170405624
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 11/28/2023

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-655L
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 11/27/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/28/2023
• 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-HQ190/UNKNOWN SERIAL NUMBER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male