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	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the affected device was discarded, the evaluation was based on the information provided.After surgery, there were no signs that would indicate failed clip application and resection.In addition, the review of the production related quality records showed no anomalies, that would indicate a technical problem, therefore a device related failure can be excluded.Detachment of clips in endoscopy or the dehiscence of staples in surgery are known risks of procedures on digestive organs, happen with a certain probability and are part of the general prodedural and postprocedural risk of such interventions.The physician in charge had not undergone dedicated ftrd training.The root cause of the problem stays unclear.The complication of postsurgical clip detachment is known and described in the ftrd risk management file.In addition, a remaining risk is pointed out in the instruction of use.A device user training is scheduled with the physician in charge.
Event or Problem Description
It was reported, that after removal of a gist in the stomach, the patient suffered dull pain the day after surgery.After 10 days the patient returned to the hospital with severe pains, and it was determined that the clip has become detached from the stomach wall.The surgeon found a 1 cm perforation and the clip floating.The clip could be removed from the stomach and the perforation closed by surgery.After four days the patient was discharged from the hospital without any further treatment.
Event or Problem Description
It was reported, that after removal of a gist in the stomach, the patient suffered dull pain the day after surgery.After 10 days the patient returned to the hospital with severe pains, and it was determined that the clip has become detached from the stomach wall.The surgeon found a 1 cm perforation and the clip floating.The clip could be removed from the stomach and the perforation closed by surgery.After four days the patient was discharged from the hospital without any further treatment.
Additional Manufacturer Narrative
Since the affected device was discarded, the evaluation was based on the information provided.After surgery, there were no signs that would indicate failed clip application and resection.In addition, the review of the production related quality records showed no anomalies, that would indicate a technical problem, therefore a device related failure can be excluded.Detachment of clips in endoscopy or the dehiscence of staples in surgery are known risks of procedures on digestive organs, happen with a certain probability and are part of the general procedural and postprocedural risk of such interventions.The physician in charge had not undergone dedicated ftrd training.The root cause of the problem stays unclear.The complication of postsurgical clip detachment is known and described in the ftrd risk management file.In addition, a remaining risk is pointed out in the instruction of use.A device user training is scheduled with the physician in charge.

• 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: 19246836
• Report Number: 3006696607-2024-00004
• Device Sequence Number: 6590394
• Product Code: PKL
• UDI-Device Identifier: 04260206310655
• UDI-Public: 04260206310655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200684
• 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,Followup
• Report Date (Section B): 10/09/2024

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: 04/09/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Weight: 60 KG