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

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

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Event Description

Olympus medical systems corp. (omsc) received a literature titled "the value of endoscopic resection for non-ampullary duodenal lesions: a single-center experience". The literature reported the result of 84 patients with non-ampullary duodenal lesions who underwent endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) procedure using olympus "dual knife or an insulation-tipped (it) nano knife" and other device. In the literature, the following complications have been reported to have occurred. Delayed bleeding (2 cases). Perforation (9 cases). Delayed perforation (1 case). The literature states as follows, "delayed bleeding was noted in 2 cases (2. 4%), which had undergone emr, both with tumors located in the descendant duodenum. Bleeding was controlled successfully with endoscopic electrocoagulation and hemoclipping. Perforation occurred during er in 9 cases(10. 7%), and all were closed immediately by hemoclips. As a result, all of these patients recovered non-operatively. One patient underwent delayed perforation and recovered non-operatively with total parenteral nutrition, gastrointestinal decompression, and intravenous antibiotics for 5 weeks. " there are not mentioned that these complications were related to the subject device in question. Based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. However, omsc assumes that "delayed perforation" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury because the literature described that the event as "gastrointestinal decompression, and intravenous antibiotics for 5 weeks". Also, omsc determined that "delayed bleeding" and "perforation" are not serious events based on the descriptions in the literature. Therefore, omsc determined that the "delayed perforation" was adverse event to submit. Omsc will submit a medical device report (mdr) depending on the event.

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.

• 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: 13172838
• MDR Text Key: 287672005
• Report Number: 8010047-2022-00928
• 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: Other,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• 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: Unkown

Patient Treatment Data

Date Received: 01/05/2022 Patient Sequence Number: 1