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

Model Number	FD-411UR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This reported event has been reported by the importer on mdr# 2951238-2022-00310.
Event or Problem Description
It is reported in the literature titled endoluminal vacuum closure of a duodenal perforation¿, a patient experienced perforation on post-operative day one after closure of a mucosal defect (using an olympus coagrasper, and 12 quickclip pro endoclips) caused by an endoscopic mucosal resection (emr) procedure of a 35mm polypoid lesion on the posterior wall of the second portion of the duodenum.Case with patient identifier (b)(6) reports device: coagrasper case with patient identifier (b)(6) reports device: quickclip pro endoclips.This literature was a case report of one patient who underwent an endoscopic mucosal resection (emr procedure of a 35mm polypoid lesion on the posterior wall of the second portion of the duodenum.This was complicated by intra-procedural bleeding of 250ml blood loss.Blood loss was stopped with the use of epinephrine injection, and a coagrasper.The mucosal defect was then closed with 12 quickclip pro endoclips.The patient developed evidence of perforation on post-operative day one.The patient was taken back to surgery on this day and the area was irrigated and widely drained.Perforation closure was not attempted at this time due to severe thickening and friability of the duodenum.Over the next 48 hours, the patient worsened clinically.Repeat images indicated uncontrolled leakage.This was managed with radiologically placed drains.The patient continued to deteriorate.Urgent pancreaticoduodenectomy surgery was considered, however his tenuous condition predicted a poor outcome.Endoluminal vacuum therapy (evt) was placed post-operative day six in an attempt to control duodenal leakage and prevent surgery.The evt sponge was changed every 3-6 days depending on drain output and the ability to maintain suction.The wound vac (wv) was replaced six times over 31 days and was removed when there was evidence of circumferential adherence of the duodenum to the retroperitoneum and no drainage was present.The patient¿s final pathology confirmed tubular adenoma with focal high-grade dysplasia and clear margins.Surveillance esophagogastroduodenoscopy (egd) at 12 months demonstrated complete closure of the defect with mild scarring and no evidence of residual or recurrent adenoma.There was no report of any olympus device malfunction in the procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.No product-related deficiencies were noted in the literature; there was no explanation on device malfunction.Based on the results of the investigation, the cause of the event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 13424029
• Report Number: 8010047-2022-02295
• Device Sequence Number: 14790783
• Product Code: KNS
• UDI-Device Identifier: 04953170251542
• UDI-Public: 04953170251542
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: FD-411UR
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: QUICKCLIP PRO ENDOCLIPS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male