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

Model Number 3152

Device Problems Loss of or Failure to Bond (1068); Break (1069)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

The scissor was returned with the shrink tubing removed from the device.The shrink tubing does not appear to be damaged.It appears that the shrink tubing was not adequately shrunk to remain tightly affixed to the scissor hub.An investigation and capa: (b)(4) have been initiated to determine the root cause and corrective action.

Event Description

During the surgery, heat shrink came off and fell into the abdominal cavity.It was removed from the abdominal cavity and there was no health problem for the patient.

• Brand Name: RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE
• Type of Device: MANUAL DETACHABLE SURGICAL INSTRUMENTS,
• Manufacturer (Section D): MICROLINE SURGICAL; 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 ; 9789229810
• MDR Report Key: 16133936
• MDR Text Key: 308748994
• Report Number: 1223422-2022-00012
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010012
• UDI-Public: 00811099010012
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962119
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3152
• Device Catalogue Number: 3152
• Device Lot Number: 00161433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1