MAUDE Adverse Event Report: SURGICAL INNOVATIONS LOGIGRASP; LOGIGRASP 320MM

Model Number	120-7800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a most recent fda inspection, this incident is being retrospectively reported.No device evaluation could be performed as the device was not returned to the manufacturer.No patient harm or death reported.The dhr was reviewed for lot 708339, part number: 120-7800, which was manufactured in feb 2016.Device history record review of the product assembly and packaging was recorded as adhering to specified requirements for final inspection and released 26th feb 2016.(b)(4).It was not possible to replicate the failure by our production engineer.The root cause of the screw falling out could not be established as device was not returned for evaluation.All logi grasps produced under lot number 708339 have been sold.No other issues have been reported relating to this batch number.A review of all complaints indicated that this is the first complaint of this nature in relation to the single use graspers and therefore is an insolated incident.
Event or Problem Description
A distributor reported a complaint to surgical innovations.The complaint details state, an incident occured at a hospital in (b)(6) with a logigrasp (120-7800) device.A screw which connects the jaws fell down in the abdominal cavity (or it was not present in the instrument) and the jaws detached from the insert.The screw could not be found.

• Brand Name: LOGIGRASP
• Common Device Name: LOGIGRASP 320MM
• Manufacturer (Section D): SURGICAL INNOVATIONS; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 7057429
• Report Number: 9680952-2017-00002
• Device Sequence Number: 1932973
• Product Code: GEI
• UDI-Device Identifier: 05051986011165
• UDI-Public: 05051986011165
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 02/22/2021
• Device Model Number: 120-7800
• Device Catalogue Number: 120-7800
• Device Lot Number: 708339
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 11/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1