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

Model Number KD-611L

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

Patient Problems Perforation (2001); No Code Available (3191)

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 serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.

Event Description

On october 28, 2020, olympus medical systems corp. (omsc) received literature titled "endoscopic full-thickness resection (eftr) without laparoscopic assistance for nonampullary duodenal subepithelial lesions: our clinical experience of 32 cases". This study was conducted endoscopic full-thickness resection (eftr) for 32 patients with nonampullary duodenal subepithelial lesions between february 2012 and january 2017. The eftr was performed using the subject device. In the literature, it was reported that 31 perforations occurred. These 31 perforations were managed successfully with endoscopic clipping. However, among these 31 patients, 3 perforations required additional treatment. The first female patient aged 56 years cases, after resection of a lesion in the anterior wall of the bulb, a 2. 5-cm defect was left and it could not be occluded by endoscopy, and then, transferred to open surgery. On the 19th day after the operation, she recovered smoothly and was discharged. The second male patient aged 50 years, after resection of a lesion in the anterior wall of the bulb, a 3. 0-cm defect was left and it was successfully occluded with endoloops and metallic clip suture. In the night after the operation, delayed perforation was suspected and a laparoscopic exploration was performed thereafter. However, perforation was not detected, and then, a drainage tube was placed near the wound. On the 6th day after the operation, he recovered smoothly and was discharged. The third male patient aged 81 years had a history of chronic obstructive pulmonary disease. During the procedure, a lesion in the anterior wall of the bulb was resected and the defect was managed successfully. In the night after the operation, he showed chest distress, shortness of breath, abdominal distension, and a decline in blood so2. Then, he was transferred to the intensive care unit for further treatment. On the 3rd day after the operation, the symptoms were alleviated. On the 10th day, he recovered smoothly and was discharged. There are no descriptions of device relevance for all adverse events in the literature. There is no description of the device's malfunction. Based on the available information, detailed information of the subject device was not provided. Whereas, omsc assumes that the perforation occurred during the procedure was related to the subject device due to required additional treatment. Therefore, omsc will submit three medical device reports (mdr) for the perforation. This is 3 of 3 reports regarding the perforation.

• 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: 10821317
• MDR Text Key: 216103674
• Report Number: 8010047-2020-08774
• Device Sequence Number: 1
• Product Code: KNS
• 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,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-611L
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/28/2020
• 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

Patient Treatment Data

Date Received: 11/11/2020 Patient Sequence Number: 1