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

Model Number	3222
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual inspection, this complaint has been confirmed.The returned tip was returned with a defective heat shrink.The heat shrink was returned with a vertical slit along side of the heat shrink.Because of the condition of the returned tip, a functional test is impossible.The tip was then evaluated under 20x magnification.Under this magnification it appears the tip may have contacted another device.This type of contact may have compromise the heat shrink material, therefore causing a small tear that made the insulation of the device ineffective.Lack of proper insulation may cause an electrical leakage or arcing.This is a one time use disposable device.These type of damages may also occur if the device was reprocessed at anytime.There were no signs of heat or electric damages noted on and or around the jaws of the device or even under the defective heat shrink.There were no signs of epoxy noted on the device.It is also possible that there was not an sufficient amount of epoxy applied to the device during the assembly process.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.The type of damages observed are the result of excessive force from another device or tool along with insufficient amounts of epoxy applied to the device during a the assembly process.An extensive search of the complaint data base was conducted on the associated lot number.No additional complaints were reported with this lot number.This was an isolated incident relative to this lot.
Event or Problem Description
During a procedure it was discovered that the heat shrink broke and fell into the patient's abdomen.The pieces were 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: 8931830
• Report Number: 1223422-2019-00024
• Device Sequence Number: 291051
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00142357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1