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 Codes	Internal Organ Perforation (1987); Bowel Perforation (2668)
Date of Event	08/05/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Since the affected device was discarded, no technical evaluation was possible and the analysis is based on the assessment of the pictures and information provided by the user.The available description leads to the conclusion that the observation of the white clip release ring was difficult due to suction applied with the endoscope.Such observation of clip release is mandated by the device's ifu.Strong suction has two effects that may hinder the view inside the cap and makes visualisation of clip deployment difficult.First, the suction moves liquid and blood into the lumen of the cap, plus an excessive amount of soft tissue, compared to the recommended grasping technique.This obstructs the view inside the cap and makes visualization of the deployment process difficult.Second, stronger suction pulls the bowel wall against the rim of the ftrd cap, which may in extrem situations lead to a counter-force at the cap that necessitates higher strength of clip detachment.In summary, related to the complexity given by the lesion and its location, the incident was caused by a multifactorial procedural complication.Duodenal perforation is a known and prevalent complication in resection of duodenal mass.It belongs to the spectrum of risks associated with such procedures, even in skilled hands and using proper instrumentation.The inspection of the production related quality records and the photographs provided by the user showed no abnormalities that indicates a product related defect.
Event or Problem Description
It was reported that a gastroduodenal ftrd was used for removal a 1.5 cm net lesion in the first part of the duodenum.While turning the handwheel of the clip release mechanism, the physician assumed that the clip had been successfully applied and performed the full thickness resection.However, clip application was visually not verified beforehand as it is required by the ifu of the product and user training.The resulting perforation was surgically closed by laparoscopic intervention.After 10 - 15 days the multimorbid patient had cardiovascular instability and dies despite icu treatment.
Event or Problem Description
It was reported that a gastroduodenal ftrd was used for removal a 1.5 cm net lesion in the first part of the duodenum.While turning the handwheel of the clip release mechanism, the physician assumed that the clip had been successfully applied and performed the full thickness resection.However, clip application was visually not verified beforehand as it is required by the ifu of the product and user training.The resulting perforation was surgically closed by laparoscopic intervention.After 10 - 15 days the multimorbid patient had cardiovascular instability and dies despite icu treatment.
Additional Manufacturer Narrative
Since the affected device was discarded, no technical evaluation was possible and the analysis is based on the assessment of the pictures and information provided by the user.The available description leads to the conclusion that the observation of the white clip release ring was difficult due to suction applied with the endoscope.Such observation of clip release is mandated by the device's ifu.Strong suction has two effects that may hinder the view inside the cap and makes visualisation of clip deployment difficult.First, the suction moves liquid and blood into the lumen of the cap, plus an excessive amount of soft tissue, compared to the recommended grasping technique.This obstructs the view inside the cap and makes visualization of the deployment process difficult.Second, stronger suction pulls the bowel wall against the rim of the ftrd cap, which may in extreme situations lead to a counter-force at the cap that necessitates higher strength of clip detachment.In summary, related to the complexity given by the lesion and its location, the incident was caused by a multifactorial procedural complication.Duodenal perforation is a known and prevalent complication in resection of duodenal mass.It belongs to the spectrum of risks associated with such procedures, even in skilled hands and using proper instrumentation.The inspection of the production related quality records and the photographs provided by the user showed no abnormalities that indicates a product related defect.
Additional Manufacturer Narrative
The followup report no 2 include the following corrections 1.Section h11: correction in accordance to 21cfr803.56_ delete information and add only the made corrections.2.Section g4: correct pma/510(k) number to 200684.(correction was made in follow-up #1) 3.Section h6: correct health effect_ clinical code e to 2668 _ bowel perforation 4.Section h6: add health effect _ impact code f _1802 _ death.

• 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: 18824043
• Report Number: 3006696607-2024-00001
• Device Sequence Number: 3047607
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 200684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2025

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: 09/20/2025
• Device Model Number: 200.72
• Device Catalogue Number: 200.72
• Device Lot Number: 846233
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024; Not provided
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 10/09/2024; 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2023
• 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: Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG