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

Model Number 200.72

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 08/05/2023

Event Type  Death  

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 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.

• Brand Name: GDFTRD
• Type of Device: 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
• MDR Text Key: 336732332
• Report Number: 3006696607-2024-00001
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K170867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG