MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number KD-645L

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

Patient Problems Chest Pain (1776); Laceration(s) of Esophagus (2398)

Event Type  Injury  

Event Description

Olympus medical systems corp. (omsc) received a literature titled "long-term outcomes of per-oral endoscopic myotomy in spastic esophageal motility disorders: a large, single-center study". The literature reported the result of 74 patients with spastic esophageal motility disorders (semd) who underwent per-oral endoscopic myotomy (poem) procedure using olympus triangular tip knife and other device. In the literature, the following perforation have been reported to have occurred. Insufflation-related events (15 cases). Mucosal injuries (3 cases). Mucosal barrier failure (2 cases). Delayed bleeding (1 case). The literature states as follows, "adverse events were noticed in 21 (28. 4%) cases. Mild adverse events included insufflation-related events in 15 (20. 3%) and mucosal injuries in 3 (4. 1%) patients. Moderate adverse events included mucosal barrier failure in 2 (2. 7%) and delayed bleeding in 1 (1. 4%) patient. All the cases with mild adverse events were managed intraoperatively. The cases with mucosal barrier failure at the site of mucosal incision presented 10 and 14 days after the poem procedure with symptom of chest pain. Endoscopy revealed small defect at the site of mucosal incision between the endoclips. Both the cases could be managed with intravenous antibiotics, nil-per oral, and nasojejunal tube feedings for 5 and 7 days, respectively. In the case with delayed bleeding, there was a submucosal hematoma at the previous tunnel site. There were no signs suggestive of active bleeding, and the patient could be discharged after observation for 4 days. Gerd was detected in 36 (56. 1%) patients with 24-hour ph study. " 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 assumed that the patients were hospitalized for the "mucosal barrier failure" because it was managed with nasogastric tube feedings. So, omsc determined that "mucosal barrier failure" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury. Also, the medical safety officer of the omsc commented that "delayed bleeding" is an observation hospitalization and is not serious, based on the following statement: "there were no signs suggestive of active bleeding, and the patient could be discharged after observation for 4 days. "there were no signs suggestive of active bleeding, and the patient could be discharged after observation for 4 days. " therefore, omsc determined that the "mucosal barrier failure" 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.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• 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: 13067514
• MDR Text Key: 285752749
• Report Number: 8010047-2021-16688
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K182408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-645L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 12/22/2021 Patient Sequence Number: 1