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

Model Number KD-610L

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 06/14/2015

Event Type  Injury  

Event Description

Olympus reviewed the following article: "detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy" by jin huang, yun-sheng yang, zhong-sheng lu, et al.The single-center study was aimed to determine the diagnostic potential of confocal laser endomicroscopy (cle) combined with lugol's iodine chromoendoscopy (lic) in detecting superficial esophageal squamous cell neoplasia (escn) using a histological examination of en bloc endoscopic resection (er) specimens as the standard.The lic- cle was performed in 52 enrolled patients.In the same patients, a chromoendoscopy-guided biopsy was performed by another endoscopist, and they were compared for the detection rates.The reported sensitivity, specificity, negative predictive value, and positive predictive value of chromoendoscopy-guided cle were 95.7%, 90%, 81.8%, and 97.8%, respectively.In conclusion, the study demonstrated that escn could be diagnosed reliably by lic-cle.A total of 56 lesions in 52 patients were enrolled for the study, including 16 females and 36 males (mean age, 60.5 years; range, 43-78 years).The authors used multiple olympus devices and did not specify the devices used in relation to the adverse events experienced.Therefore all olympus devices will be reported.Patient identifier (b)(6) is for kd-610l; complaint 2 is for kd-1l; complaint 3 is for fd-410lr; complaint 4 is for gif-h260; complaint 5 is for clv-260sl; complaint 6 is for gifq260j.The adverse events reported: endoscopic hemostasis was performed either with the knife or hemostatic forceps (fd-410lr; olympus optical co., ltd., (b)(4)) whenever bleeding was noted.After dissection, preventive endoscopic hemostasis was performed for any oozing or exposed vessel.Minor bleeding was encountered in all er procedures, but successful hemostasis was always achieved using thermocoagulation.No patient experienced massive hemorrhage requiring a blood transfusion or postprocedural emergent endoscopy.No delayed hemorrhage occurred.Exposure of the muscular layer during esd occurred in four cases, but no overt esophageal perforation.Treatment not specified.This is report 1 of 6 for patient identifier (b)(6) is for kd-610l.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.A supplemental report will be submitted after the related complaints are created.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

Related complaints: (b)(6) is for kd-610l.(b)(6) is for kd-1l.(b)(6) is for fd-410lr.(b)(6) is for gif-h260.(b)(6) is for clv-260sl.(b)(6) is for gif-q260j.

Manufacturer Narrative

This supplemental report is being sent to provide the related complaints for this literature article.New information added to b5.

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.

Manufacturer Narrative

This report is being supplemented to provide additional information in the following fields: b3, h6, h10.

• 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: 13586627
• MDR Text Key: 290690296
• Report Number: 8010047-2022-03439
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• 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,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-610L
• 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: 07/25/2022
• 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
• Patient Sequence Number: 1
• Treatment: FD-410LR, GIF-H260, CLV-260SL, GIFQ260J
• Patient Outcome(s): Required Intervention; Other