MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number	KD-640L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report the user's experience and the investigation findings.The complaint device(s) were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint device(s) could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications conclusion: the definitive cause of the reported events could not be established.There was no report of any olympus device malfunction reported in any procedure described in this study, therefore it is presumed that the cause of the reported events is not related to the device.
Event or Problem Description
It is reported in the literature article titled "peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy, " five patients in the peroral endoscopic myotomy (poem) group experienced an adverse event.This was a retrospective single center review of 52 consecutive poem procedures between 2012-2014, and 52 consecutive rhm procedures between 2009-2014 with the primary aim of comparing the inpatient charges incurred by patients undergoing poem or robotic heller myotomy (rhm) for the treatment of achalasia.In all poem cases, an olympus kd-640l was used.There is no report of device malfunction during any of these procedures.Five patients in the peroral endoscopic myotomy (poem) group experiencing an adverse event (pneumothorax (1), mucostomies (4).No information was provided regarding any treatment required for these reported events.This report is being submitted to report the potential that an olympus device could have caused or contributed to a reported adverse event.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11582704
• Report Number: 8010047-2021-04306
• Device Sequence Number: 16882883
• Product Code: KNS
• UDI-Device Identifier: 04953170208423
• UDI-Public: 04953170208423
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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-640L
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other