MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG DIAGNOSTIC FTRD SET

Model Number	200.76
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In summary, there is no indication of a technical failure of the device.None of the dmrs showed any deviation.The risk of causing a perforation is indicated in the instruction for use.Moreover, it is addressed in user trainings we perform.It is recommended to verify clip application visually in the endoscope image before resecting the target tissue.In conclusion, the determined root cause is a procedural complication, not a technical failure.
Event or Problem Description
A diagnostic ftrd set (dftrd), manufacturer ovesco endoscopy ag, was used for an endoscopic full thickness resection of a polyp at appendical orifice.The endoscopic interventionist assumed that the clip of the diagnostic ftrd set in question had been applied and, hence, proceeded to perform the full thickness resection.However, clip application was visually not verified beforehand.The caused perforation was closed by surgery.As reported the patient recovered uneventfully.

• Brand Name: DIAGNOSTIC FTRD SET
• Common Device Name: DIAGNOSTIC FTRD SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-str. 9; tübingen, deutschland 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOSCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• Manufacturer Contact: eva kühfuss ; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• MDR Report Key: 15410482
• Report Number: 3006696607-2022-00005
• Device Sequence Number: 5640339
• Product Code: PKL
• UDI-Device Identifier: 04260206311072
• UDI-Public: 4260206311072
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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 Expiration Date: 04/30/2023
• Device Model Number: 200.76
• Device Catalogue Number: 200.76
• Device Lot Number: 826006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White