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

Model Number 3152

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

The scissor tip was forwarded to quality engineering for evaluation.A plastic bag with a scissor assembly and a loose shrink tube were examined.The scissor when examined under magnification showed no indication of damage and functioned properly when attached to the handpiece.The shrink tube was "shrunk" which would indicate that it was subjected to heat during the assembly process.When the tube was reinstalled, it appears to be somewhat loose and had some appearance of stretching.Upon examination under magnification, it appears that the shrink tube may have been in contact with a canula or some object causing the shrink tubing to be forced free from the scissor.

Event Description

Tubing casing broke off in patient complaint: scissor tip was screwed onto handle 0 issues noted.Surgeon used scissors inside pt.- pulled out scissors and said "oh its grabbing when i pulled it out" i inspected the tip - noted 'something was different' but didn't realize the tubing casing was off until surgeon looked in abdomen & found the piece.

• 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; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915
• MDR Report Key: 15283243
• MDR Text Key: 305418389
• Report Number: 1223422-2022-00006
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010012
• UDI-Public: 00811099010012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2022

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: 3152
• Device Catalogue Number: 3152
• Device Lot Number: 00160138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• 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