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

Model Number KD-620LR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Gastrointestinal Problem (4491)

Event Type  Injury  

Manufacturer Narrative

This reported is being submitted to report the events in the article and to provided investigation findings.The device(s) referenced in this report has not been returned to olympus for evaluation.There for a physical evaluation could not be completed.The device history record (dhr) for the complaint device(s) could not be completed because the serial number(s) were not provided.Olympus however does not ship any devices that don't meet all design and safety specifications.Conclusion: the definitive cause of the reported events could not be established.There was no device malfunction reported in any case described in the literature article.The adverse effects described in the article are all anticipated potential events related to the procedure or patient underlying disease state (for which the procedure would be performed).This event has been reported by the importer on mdr# 2951238 - 2021 - 00296.

Event Description

It is reported in the literature article titled "outcomes of per oral endoscopic pyloromyotomy in gastroparesis worldwide." an unspecified number of patients experienced post-procedural bleeding, pyloric ulcer, tension capnoperitoneum, or post procedural pulmonary embolism during or following a per oral endoscopic pyloromyotomy (poep) procedure.One patient death was reported not to be procedurally related.This article is a meta analysis of other research studies.The precise number of patients experiencing adverse effects as well as the treatment required was not provided.In the article, it doesn't specify which (or if any) olympus device was used in the procedures.It mentions two olympus devices as common choices for the procedure.Without specific details, one report will be submitted to report the possibility that an olympus triangle tip knife, or an olympus hook tip knife could have caused or contributed to the reported aes.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11416802
• MDR Text Key: 247084005
• Report Number: 8010047-2021-03324
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2021

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
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other