MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW SUPER ATRAUMATIC FENESTRATED GRASPER TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3642
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A microline grasper tip- one half of grasping jaw appears to have sheared off whilst in abdomen.Broken piece removed and grasping tip removed from applicator when removed from abdomen.Both kept for examination.Surrounding area and tip checked- everyone happy that nothing left inside and all pieces of tip retrieved.All other grasping tips with same lot number removed from shelves as a precaution.There was no adverse affects with patient.The patient suffered no injury.The incident was an actual event.
Additional Manufacturer Narrative
The device was returned, decontaminated, visually inspected and lab evaluated.After evaluation the complaint is confirmed.The jaw was found to be broken at the attachment point of the jaw to the blade.This is the weakest point of the part based on the design, this is the point we would expect to break via high forces.The broken edge was observed under microscope and no mim voids were seen at that site.It is possible that high force was placed on a rigid material and caused the jaw to fracture.This part also may have been pre-stressed during the grab test at msi - which has since been eliminated.

• Brand Name: RENEW SUPER ATRAUMATIC FENESTRATED GRASPER TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 13942400
• Report Number: 1223422-2022-00002
• Device Sequence Number: 4612201
• Product Code: GEI
• UDI-Device Identifier: 00811099010166
• UDI-Public: 00811099010166
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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 Expiration Date: 07/28/2026
• Device Model Number: 3642
• Device Catalogue Number: 3642
• Device Lot Number: 00157593
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2021
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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