MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG OTSC SYSTEM SET

Model Number	12/6 GC
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product in question was desposed by the user it could not be analysed by the importer or the manufacturer.Furthermore, insufficient information was provided and we were not able to get more information about the technical problem described in the report by the medical user.Therefore, it cannot be conclusively assessed why the user was not able to deploy the clip.A review of all device master records of this otsc system set's lot showed that they were manufactured according to specification.
Event or Problem Description
(b)(6) from (b)(6) reports: "ovesco over the scope clip would not deploy during esophagogastroduodenoscopy.".

• 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: 9902114
• Report Number: 3006696607-2020-00002
• Device Sequence Number: 2742041
• Product Code: PKL
• UDI-Device Identifier: 04260206310136
• UDI-Public: 4260206310136
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• 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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 12/6 GC
• Device Catalogue Number: 100.27
• Device Lot Number: 818014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR