MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW FENESTRATED GRASPER TIP, DISPOSABLE; FORCEPS, LAPAROSCOPIC

Model Number	3222
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a late mdr submission.The adverse event occurred on (b)(6) 2018, but was not reported to the manufacturer until (b)(6) 2018.The customer confirmed that the device was discarded and therefore could not be returned for an investigation.Since an investigation cannot be performed, the problem cannot be confirmed and a root cause cannot be determined.A lot history search was performed and there were no other complaints related to this lot number.
Event or Problem Description
During a surgical procedure, the heat shrink came off from the renew fenestrated grasper tip, but did not fall into the patient.The malfunctioned tip was not used in the patient and the surgeon used a new tip.There was no harm to the patient.

• Brand Name: RENEW FENESTRATED GRASPER TIP, DISPOSABLE
• Common Device Name: FORCEPS, LAPAROSCOPIC
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7806356
• Report Number: 1223422-2018-00024
• Device Sequence Number: 19216133
• Product Code: GEI
• UDI-Device Identifier: 00811099010067
• UDI-Public: 00811099010067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 12/28/2022
• Device Model Number: 3222
• Device Catalogue Number: 3222
• Device Lot Number: 00138704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1