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 Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.Based on the reported event, it is presumed that the reported complications were not due to the malfunction of the device.

Event Description

On january 28, 2020, olympus medical systems corp.(omsc) received a literature titled ¿endoscopic full-thickness resection for gastric subepithelial tumors originating from the muscularis propria : a 69-case series¿.The literature reported the result of 69 cases (the ratio of male-to-female ratio was 25:44.The median age of the patients was 56.62 years.) of the endoscopic full-thickness resection for gastric subepithelial tumors originating from the muscularis propria from september 2009 to july 2016.The literature indicated that single use electrosurgical knife kd-610l and single use electrosurgical knife kd-620lr might be used.The literatures reported that complications occurred as follows; delayed perforation: 1 case.Peritonitis: 2 cases.Delayed bleeding: 1 case.Esophageal stenosis: 1 case.Further detailed information such as the relationship between the subject device and all of the reported complications could not been obtained at present.Therefore, according to the number of the type of complications known and the number of olympus device used for procedure, omsc is submitting eight medical device reports.This is a report on peritonitis associated with the subject device and six of eight reports.

• 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: 9725636
• MDR Text Key: 192680239
• Report Number: 8010047-2020-01431
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other