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

Model Number	3222
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and investigated.There were signs of physical damages noted on the jaws of the returned device.The device was returned with a damaged yoke slot.This means that the device at some point had experienced a large amount of force that then caused the tip to become non-functional.This complaint is confirmed.Because of the condition of the returned tip, a true functional test could not be conducted.Although a functional test was not possible, a visual inspection of the device was conducted.The device was returned with all its components still intact with in their original position expect for the yoke pin.The yoke pin was still lodged into the device due to a possibility of excessive force, the yoke pin was no longer in the yoke slot.If the position of the yoke pin changes at any time out side of its intended use, the dimensions of the jaws will be compromised.If the force applied on the grasper exceeds (b)(6) the functionality and dimension of the jaws will also be compromised.For final inspection requirements, all devices are 100% inspected for damages and imperfections.It is not likely that the device left microline inc in this condition.This complaint is confirmed.A possible root cause may be due to excessive force applied to the jaws.
Event or Problem Description
The jaw broke on the fenestrated grasper during a procedure and fell into the patient.The piece was retrieved.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: 8875205
• Report Number: 1223422-2019-00022
• Device Sequence Number: 19521621
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: 04/28/2024
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00146600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 72