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

Model Number	KD-612L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Stenosis (2263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device has not been returned.The legal manufacturer's investigation has been completed.The device history records (dhr) for this device could not be reviewed since the lot number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.
Event or Problem Description
Olympus reviewed the following literature titled "long-term outcomes of esophageal squamous cell carcinoma with invasion depth of pathological t1a-muscularis mucosae and t1b-submucosa by endoscopic resection followed by appropriate additional treatment".Literature summary: endoscopic resection (er) is indicated for a wide range of superficial esophageal squamous cell carcinomas (esccs)w.E examined the long-term outcomes in patients with pathological (p) invasion of escc into the t1a-muscularis mucosae (mm) and t1b-submucosa (sm) after er, for which data on prognosis are limited.Type of adverse events/number of patients: event 1:stenosis (mm 13.9%, sm1 10.7%, sm2 8.7%), event 2:perforation (mm 1.3%), event 3:delayed bleeding (mm 0.6%), event 4:local recurrence(10), metastatic recurrence(8), regional ln metastatic recurrence(6), distant metastatic recurrence(3), ln metastasis detected in esophagectomy(4), overall metastasis(12), event 5:death due to escc(2), event 6:death due to other causes(49).The deaths have been determined to be not reportable.This article includes 2 reports: (b)(6) ae for kd-650l and (b)(6) ae for kd-612l.This is report 2 of 2 for (b)(6) ae for kd-612l.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the author.
Event or Problem Description
Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events.There was no malfunction of the olympus devices.The author stated the following treatments/procedures were performed: endoscopic balloon dilation for stenosis, conservative treatment after clipping for perforation, and emergency endoscopy to perform hemostasis for delayed bleeding.Recurrence was addressed with multidisciplinary treatment involving chemotherapy, radiation therapy, and surgery.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• Common Device Name: 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: 14917218
• Report Number: 8010047-2022-11332
• Device Sequence Number: 16614806
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092309
• 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): 08/03/2022

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-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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown