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

Model Number	3222
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and investigated.Investigation findings revealed the customer complaint was confirmed.The device was returned with a broken jaw at the hinge point.Because of the condition of the returned device, a functional test is not possible.The type of damages observed are the result of excessive force or stress applied to the tip of the device.If jaws of the device are activated on hard material or used outside of its intended, use in any way, the dimensions of the jaws will be compromised.If the force applied on the grasper exceeds 9.9lbs the tip will break.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.A device complaint history check was conducted on part number 3222, and there have been zero similar complaints from this part number in the past year.This is an isolated incident.
Event or Problem Description
One of the jaws on the graspers broke off during a procedure and needed to be retrieved from inside of 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: 8363442
• Report Number: 1223422-2019-00005
• Device Sequence Number: 1914731
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 117