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

Model Number	KD-640L
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was not returned to olympus; therefore, the cause of the reported event could not be confirmed.However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that at the end of a per oral pyloromyotomy (pop) procedure, the tip of the knife and a piece of the stem was observed missing from the device.An egd-esophagogastroduodenoscopy and fluoroscopy were performed to determine the location of distal end/knife and it added an additional 20-30 minutes under anesthesia for these extra procedures.The device fragments were retrieved from the patient's stomach using biopsy forceps.The intended procedure was completed and there was no patient injury reported.No devices or equipment were replaced.In addition, the device was visually inspected by the nurse and the physician prior to insertion into of device into an olympus 190 scope (model not specified); no anomalies were noted.Per the physician, the knife was noted to be slightly stiff to insert.However, there was no restriction of the scope and no difficulty withdrawing knife from scope.No sparking was observed.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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
• MDR Report Key: 8143240
• Report Number: 2951238-2018-00745
• Device Sequence Number: 268460
• Product Code: KNS
• UDI-Device Identifier: 04953170208423
• UDI-Public: 04953170208423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-640L
• Device Lot Number: 87K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1