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

Model Number 3142

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 304510491
• Report Number: 1223422-2022-00003
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3142
• Device Catalogue Number: 3142
• Device Lot Number: 00160258
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1