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

Model Number	3142
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is question was received and inspected.It was returned with 1/2 of heat shrink.Observed that heat shrink was shriveled indicating that the tip was reprocessed at the hospital.This most likely caused the heat shrink to crack/break in two length wise.
Event or Problem Description
Name plate collar split in half intraoperatively unable to find one half of the piece.The dislodged (plastic portion) portion of the tip was never recovered after the procedure.Sales rep indicates that the tip split longitudinally.

• Brand Name: RENEW ENDOCUT SCISSOR TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL, INC.; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL, INC.; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd; suite 1500; beverly, MA 01915
• MDR Report Key: 14958471
• Report Number: 1223422-2022-00003
• Device Sequence Number: 6906218
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2022

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: 3142
• Device Catalogue Number: 3142
• Device Lot Number: 00160258
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown