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

Model Number	3252
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated, visually inspected and lab evaluated.After evaluation the complaint is confirmed, the device was returned with a defective jaw.Visual inspection confirmed that one of the jaws on the tip was no longer functional.The tip was observed under the microscope, and a portion of the jaw is completely fractured, see attached file "fractured jaw".The area where the fracture occurred is where the yoke pin initiates grasping/releasing of the jaws by moving along a groove within jaw.When the weak point around this groove was fractured, the jaw become disconnected from the yoke pin and became defective root cause: unable to determine exact root cause, jaw may have been manufactured with compromised material which made it weaker.Excessive force actuating the tip also could have weakened the material over time to eventually cause a failure.Will monitor for similar complaints in the future to determine if this lot had weakened, defective jaws.
Event or Problem Description
A piece of the tip broke off during surgery.Anesthesia time was extended for 30 minutes while the piece was retrieved.A post operative x-ray was performed to ensure no piece was left in the patient.

• Brand Name: RENEW LAPCLINCH GRASPER TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMEMNTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly, ma
• MDR Report Key: 9765469
• Report Number: 1223422-2020-00006
• Device Sequence Number: 11376550
• Product Code: GEI
• UDI-Device Identifier: 00811099010074
• UDI-Public: 00811099010074
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 08/28/2024
• Device Model Number: 3252
• Device Catalogue Number: 3252
• Device Lot Number: 00148667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR