MAUDE Adverse Event Report: OVESCO ENDOCOPY AG GDFTRD; GASTRODUODUNAL FTRD SYSTEM SET

Model Number	200.72
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the affected device was discarded, the evaluation was based on the assessment of pictures provided by the user.The abdominal aspect (pictures of the surgical intervention to treat the complication) two days after the endoscopic intervention shows a detachment of the clip and a necrotic appearance of the margins of the resection site.One could assume that the whitish margins indicate a transmural electrical damage.The pictures sent to us indicate indicate anastomotic failure at the resection site.The inspection of the production related quality records showed no abnormalities that indicates a product related defect.Therefore, it can be concluded that a procedural complication with multifactorial cause is very likely.
Event or Problem Description
Two days after a successful full-thickness biopsy in the stomach with the gdftrd, the clip lost its hold on the tissue, resulting in a perforation.The perforation had to be closed surgically.The patient recovered uneventful from surgery without any further treatment.

• Brand Name: GDFTRD
• Common Device Name: GASTRODUODUNAL FTRD SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, baden württemberg 72076 ; GM 72076
• MDR Report Key: 18027682
• Report Number: 3006696607-2023-00003
• Device Sequence Number: 20321893
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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 Expiration Date: 12/27/2025
• Device Model Number: 200.72
• Device Catalogue Number: 200.72
• Device Lot Number: 847774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG