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

Model Number KD-650Q

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

Patient Problems Abdominal Pain (1685); Bowel Perforation (2668)

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 (b)(6) 2021, olympus medical systems corp. (omsc) received the literature titled "endoscopic submucosal dissection for colorectal neoplasms in proximity or extending to a diverticulum". In this study, 47 colorectal lesions treated with endoscopic submucosal dissection (esd) between january 2014 and april 2019 were included. The 47 subjects consisted of 27 male and 20 female patients with a mean age of (b)(6). In the literature, it was reported that the following. "delayed perforation, delayed bleeding, fever, and abdominal pain occurred in 1, 1, 4, and 5 patients, respectively. "two days after the esd, a strong tenderness was observed in the right lower abdomen, and ct revealed free air around the treatment area. The patient was diagnosed as having developed post operative delayed perforation, and emergency surgery was performed. Based on the available information, reported delayed perforation, delayed bleeding, fever, abdominal pain were not reported in a direct relationship with the olympus products. However, omsc assumes that the delayed perforation and the delayed bleeding might be related to the subject device since the subject device was used for the procedure. And, omsc assumes that the delayed perforation might be caused or contributed to a death or serious injury. Omsc assumes that the delayed bleeding, the fever and the abdominal pain were not serious due to the following report: *delayed bleeding was successfully controlled by endoscopic hemostasis. *four patients developed high-grade fever (38°c) and five patients developed transient severe abdominal pain; however, all of these patients improved conservatively with antibiotics. Therefore, omsc assumes that the delayed perforation was an adverse event to submit. Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided. There is no description of the device's malfunction. Omsc will submit one medical device report (mdr) of the subject device for the delayed perforation.

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 nov. 8, 2021, olympus medical systems corp. (omsc) received the literature titled "endoscopic submucosal dissection for colorectal neoplasms in proximity or extending to a diverticulum". In this study, 47 colorectal lesions treated with endoscopic submucosal dissection (esd) between january 2014 and april 2019 were included. The 47 subjects consisted of 27 male and 20 female patients with a mean age of 72. 9 ± 9. 8 years. In the literature, it was reported that the following. *delayed perforation, delayed bleeding, fever, and abdominal pain occurred in 1, 1, 4, and 5 patients, respectively. *two days after the esd, a strong tenderness was observed in the right lower abdomen, and ct revealed free air around the treatment area. The patient was diagnosed as having developed post operative delayed perforation, and emergency surgery was performed. Based on the available information, reported delayed perforation, delayed bleeding, fever, abdominal pain were not reported in a direct relationship with the olympus products. However, omsc assumes that the delayed perforation and the delayed bleeding might be related to the subject device since the subject device was used for the procedure. And, omsc assumes that the delayed perforation might be caused or contributed to a death or serious injury. Omsc assumes that the delayed bleeding, the fever and the abdominal pain were not serious due to the following report: *delayed bleeding was successfully controlled by endoscopic hemostasis. *four patients developed high-grade fever (>38°c) and five patients developed transient severe abdominal pain; however, all of these patients improved conservatively with antibiotics. Therefore, omsc assumes that the delayed perforation was an adverse event to submit. Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided. There is no description of the device's malfunction. Omsc will submit one medical device report (mdr) of the subject device for the delayed 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: 12921878
• MDR Text Key: 286062972
• Report Number: 8010047-2021-15457
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-650Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• 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: 12/02/2021 Patient Sequence Number: 1