MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG OTSC SYSTEM SET

Model Number	11/6A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pictures of the otsc system set in question taken by the importer (b)(4) do not show any deviation from specifications.Neither information on assembly nor precise information on the actual procedure and circumstances of the failure were provided by the user.Therefore, it cannot be conclusively assessed why the user was not able deploy the clip.A review of all device master records for this otsc system set's lot showed that they were manufactured according to specifications.
Event or Problem Description
(b)(6) from (b)(6) reports: "ovesco clamp would not deploy; tried twice; equipment malfunction.".

• Brand Name: OTSC SYSTEM SET
• Common Device Name: OTSC SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; friedrich-miescher-strasse 9; tuebingen, 72076 ; GM 72076
• MDR Report Key: 9859457
• Report Number: 3006696607-2020-00001
• Device Sequence Number: 2496905
• Product Code: PKL
• UDI-Device Identifier: 04260206310075
• UDI-Public: 4260206310075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2022
• Device Model Number: 11/6A
• Device Catalogue Number: 100.09
• Device Lot Number: 819558
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 88