MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3152
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We received an fda medwatch report (mw5091846) on 01/06/2020.The reported incident is a heat shrink failure on a scissor tip.The catalog number listed was 3152r and the lot number 391406.Microline surgical does not use an r in their disposable tip catalog numbers and this lot # is not a microline number.The information of the reporting facility was not provided on the medwatch report.Therefore we cannot contact the reporter for more information or to have the device returned.We believe that the microline surgical scissor tip was reprocessed by another organization prior to this failure.Microline surgical disposable tips are single use devices and should not be reprocessed or reused.The instructions for use (ifu) and label clearly provide this information.As such, we can not be responsible for a failure of a reprocessed device.
Event or Problem Description
A third of the protective sheath came off the end of the scissor tip.

• Brand Name: RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 9560100
• Report Number: 1223422-2020-00004
• Device Sequence Number: 19394581
• Product Code: GEI
• UDI-Device Identifier: 00811099010012
• UDI-Public: 00811099010012
• Combination Product (Y/N): N
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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 Model Number: 3152
• Device Catalogue Number: 3152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1