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

Model Number	3222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual investigation, this complaint is confirmed.The device was returned with a clean broken off jaw.Because of the condition of the returned device, a functional test could not be performed.Possible causes of the failure are excessive force or stress applied to the tip of the device during installation or a manufacturing defect.A design review is taking place to address the issue and prevent recurrence.
Event or Problem Description
One side of the grasper broke off in patient during laparoscopic case.It was a clean break and one piece was retrieved from the patient.There was no harm to the patient.

• Brand Name: RENEW 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
• MDR Report Key: 11396096
• Report Number: 1223422-2021-00001
• Device Sequence Number: 13757844
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: 12/28/2025
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00154760
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1