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

Model Number KD-640L

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

Patient Problems Dyspnea (1816); Pleural Effusion (2010)

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "parapneumonic effusion and tension pneumothorax after diverticular peroral endoscopic myotomy in a woman with large epiphrenic diverticulum: a case report and literature review".The literature reported the result of patients with large epiphrenic diverticulum who underwent diverticular peroral endoscopic myotomy procedure (d-poem) using olympus triangle-tip knife ((b)(4)) and another device.In the literature, it was reported complication after the procedure as follows; subcutaneous emphysema the literature describes the patient's symptoms and treatment as follows."subcutaneous emphysema occurred on the right side of the neck and chest immediately after d-poem, without any unstable vital signs being seen ((b)(6)).However, exertional dyspnea with left pleuritic pain developed on postoperative day 3; a chest ct showed massive pleural effusion and pulmonary atelectasis of the left side ((b)(6)), indicating uncomplicated parapneumonic effusion via thoracentesis.A chest tube was immediately inserted with maintenance using negative pressure, but a follow-up esophagoscopy uncovered a spontaneous mucosal defect within ed on postoperative day 5 ((b)(6)).I applied endoclips for complete closure of the mucosal defect.The following day tension pneumothorax was noted via a follow-up chest radiograph and a second follow-up esophagoscopy on postoperative day 11 was performed due to continuous pneumothorax under maintenance of negative pressure via a chest tube.This manifested an enlarged mucosal defect with suspicious communication to the pleural space; therefore, mucosal closure utilizing an endoloop and endoclips was thoroughly applied ((b)(6)).On postoperative day 16, a third follow-up esophagoscopy revealed a healing ulcer as well as resolution of the pneumothorax; the chest tube was removed the following day ((b)(6)).A barium esophagography showed the decreasing size of ed and a smooth passage to the gastric lumen without any additional leakage on postoperative day 22 ((b)(6)).The patient attempted the intake of water and a clear liquid diet on postoperative day 17 after removal of the chest tube and has since tolerated a liquid diet.I prescribed antibiotics unasyn 3 g every 12 hours for a total of 22 days from postoperative day 1 for subcutaneous emphysema immediately after d-poem and discontinued the medication one day prior to discharge.The patient was then discharged on postoperative day 23 in a stable condition." 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, the omsc assumed that the patient's hospitalization was prolonged due to the treatment of "subcutaneous emphysema." therefore, omsc determined that this event was a serious complication.Therefore, omsc assumes that the event might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.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.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "parapneumonic effusion and tension pneumothorax after diverticular peroral endoscopic myotomy in a woman with large epiphrenic diverticulum: a case report and literature review".The literature reported the result of patients with large epiphrenic diverticulum who underwent diverticular peroral endoscopic myotomy procedure (d-poem) using olympus triangle-tip knife (kd-640l) and another device.In the literature, it was reported complication after the procedure as follows; - subcutaneous emphysema the literature describes the patient's symptoms and treatment as follows."subcutaneous emphysema occurred on the right side of the neck and chest immediately after d-poem, without any unstable vital signs being seen (fig.3a).However, exertional dyspnea with left pleuritic pain developed on postoperative day 3; a chest ct showed massive pleural effusion and pulmonary atelectasis of the left side (fig.3b), indicating uncomplicated parapneumonic effusion via thoracentesis.A chest tube was immediately inserted with maintenance using negative pressure, but a follow-up esophagoscopy uncovered a spontaneous mucosal defect within ed on postoperative day 5 (fig.3c).I applied endoclips for complete closure of the mucosal defect.The following day tension pneumothorax was noted via a follow-up chest radiograph and a second follow-up esophagoscopy on postoperative day 11 was performed due to continuous pneumothorax under maintenance of negative pressure via a chest tube.This manifested an enlarged mucosal defect with suspicious communication to the pleural space; therefore, mucosal closure utilizing an endoloop and endoclips was thoroughly applied (fig.3d, e).On postoperative day 16, a third follow-up esophagoscopy revealed a healing ulcer as well as resolution of the pneumothorax; the chest tube was removed the following day (fig.3f).A barium esophagography showed the decreasing size of ed and a smooth passage to the gastric lumen without any additional leakage on postoperative day 22 (fig.3g).The patient attempted the intake of water and a clear liquid diet on postoperative day 17 after removal of the chest tube and has since tolerated a liquid diet.I prescribed antibiotics unasyn 3 g every 12 hours for a total of 22 days from postoperative day 1 for subcutaneous emphysema immediately after d-poem and discontinued the medication one day prior to discharge.The patient was then discharged on postoperative day 23 in a stable condition." 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, the omsc assumed that the patient's hospitalization was prolonged due to the treatment of "subcutaneous emphysema".Therefore, omsc determined that this event was a serious complication.Therefore, omsc assumes that the event might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• 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: 12974128
• MDR Text Key: 286063370
• Report Number: 8010047-2021-15866
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208423
• UDI-Public: 04953170208423
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• 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: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-640L
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female