MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-612

Model Number KD-612L

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

Patient Problems Perforation (2001); Stenosis (2263); Aspiration Pneumonitis (4455)

Event Date 08/22/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Event Description

It is reported in the literature titled ¿long term clinical outcomes of patients diagnosed with pt1a muscularis mucosae with lymphovascular invasion or pt1b after endoscopic resection for ct1n0m0 esophageal squamous cell carcinoma,¿ patients experienced adverse events during/after procedures using olympus devices.Case with patient identifier (b)(6) reports gif-2t240.Case with patient identifier (b)(6) reports gif-q20j.Case with patient identifier (b)(6) reports kd-650l.Case with patient identifier (b)(6) reports kd-612l.Background endoscopic resection (er) is performed for early esophageal squamous cell carcinoma (escc) cases.Additional esophagectomy or chemoradiotherapy is recommended for non-curative resection (ncr) even with pathologically negative vertical margins (pvm0); however, their clinical outcomes remain unknown.We examined the long-term clinical outcomes of ncr for esccs according to additional treatments.Methods we retrospectively analyzed the data of patients who underwent er for ct1n0m0 escc between 2009 and 2017 judged to have ncr, which defined when pathologically diagnosed as invading the submucosa (sm) or muscularis mucosae (mm) involving lymphovascular invasion (lvi), pvm0, and endoscopically judged as negative horizontal margin.Additional esophagectomy (involving three-fold lymphadenectomy), chemoradiotherapy [mainly cisplatin and 5-fuorouracil with concurrent radiotherapy (41.4 gy)], or observation was undertaken.Thereafter, computed tomography was performed every 6¿12 months.The cumulative recurrence (crr) and recurrence-free survival (rfs) rates were evaluated.Results eighty-nine patients were included.Among them, 14 had pathologically diagnosed pmm with lvi; 9 and 6, and 32 and 28 patients had psm1 and psm2 without and with lvi.Twenty-one patients underwent observation, whereas 18 and 50 underwent esophagectomy and chemoradiotherapy.During the 60.6-month median follow-up period, nine patients had recurrence; among them, six patients had occurrence at>4 years after er.The 5-year crr/rfs rates were 35.7%/48.1%, 13.4%/80.4%, and 0.0%/98.0% in the observation, esophagectomy, and chemoradiotherapy groups, respectively (observation vs.Chemoradiotherapy).Conclusion: additional treatments showed better long-term outcomes than observation for patients with ncr.As recurrence may occur at>4 years after er, careful long-term follow-up examinations are needed.Esophageal perforation occurred in two patients (2.2%), and esophageal stenosis after er occurred in 10 patients (11.2%) as er-related aes.Regarding the aes of ope, grade = iiia aes occurred in five patients (27.8%) with six aes, and esophageal stenosis after ope occurred in three patients (16.7%).Regarding the acute crt-related aes, some grade = 3 aes were reported, including a neutrophil count decrease (n = 14, 28.0%), platelet count decrease (n = 3, 6.0%), and esophagitis (n = 3, 6.0%).Esophageal stenosis after crt occurred in three patients (6.5%), except for four patients with esophageal stenosis after er.Moreover, grade = 2 pneumonitis occurred in three patients (6.0%) as a late ae.No grade 5 aes were observed after any treatment.Meanwhile, seven patients died from other diseases.The causes of death were respiratory failure, advanced gallbladder cancer, heart failure, and unknown in the observation group; respiratory failure and pneumonia in the ope group; and sudden death in the crt group.There is no report of olympus device malfunction reported in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information in b5 and d4.

Event Description

Additional information provided by the author/physician: it is unlikely the olympus device caused or contributed to the reported adverse events.There was no malfunction of the olympus device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• 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: 14790624
• MDR Text Key: 294939560
• Report Number: 8010047-2022-10695
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• 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,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-612L
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other