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

Model Number	3152
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1223422-2022-00006
• Device Sequence Number: 2406845
• Product Code: GEI
• UDI-Device Identifier: 00811099010012
• UDI-Public: 00811099010012
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown