MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number	HX-202LR
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Type of Reportable Event	Serious Injury
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 esophagogastro- duodenoscopy (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.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13424165
• Report Number: 2951238-2022-00311
• Device Sequence Number: 17360222
• Product Code: PKL
• UDI-Device Identifier: 04953170345142
• UDI-Public: 04953170345142
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2022
• Report Date (Section F): 01/05/2022

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: HX-202LR
• Device Lot Number: UNKNOWN-LITERATURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COAGRASPER.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male