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

Model Number	KD-1L-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem 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.The adverse events reported: endoscopic hemostasis was performed either with the knife or hemostatic forceps (fd-410lr; olympus optical co., ltd., tokyo, japan) 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.There are 6 reports for this article: patient identifier (b)(6) is for kd-610l.Patient identifier (b)(6) is for kd-1l.Patient identifier (b)(6) is for fd-410lr.Patient identifier (b)(6) is for gif-h260.Patient identifier (b)(6) is for clv-260sl.Patient identifier (b)(6) is for gif-q260j.This is report 2 of 6 for patient identifier (b)(6) is for kd-1l.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.See update in d4.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: ELECTROSURGICAL KNIFE
• Common Device Name: 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: 13653077
• Report Number: 8010047-2022-03772
• Device Sequence Number: 5801487
• Product Code: KGE
• UDI-Device Identifier: 04953170037702
• UDI-Public: 04953170037702
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KD-1L-1
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FD-410LR, CLV-260SL.; GIF-H260, GIF-Q260J.; KD-610L.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown