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

Model Number	120-7800
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a most recent fda inspection, this incident is being retrospectively reported.Device evaluation could not be performed, as device was not returned to surgical innovations.The dhr was reviewed for lot 708338, part number: 120-7800, which was manufactured march 2016.Device history record review of the product assembly and packaging was recorded as adhering to specified requirements for final inspection and released on 24 march 2016.(b)(4).No other complaints have been raised in relation to its batch number.The root cause of the screw falling out could not be established as device was not returned for evaluation.
Event or Problem Description
A distributor reported a complaint to surgical innovations.During a procedure undertaken at a hospital in (b)(6), a retaining rivet jaw mechanism became loose causing a piece of the device to fall into the patient.Attempts to recover the piece of the device have been unsuccessful.

• 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: 7057452
• Report Number: 9680952-2017-00003
• Device Sequence Number: 19203207
• Product Code: GEI
• UDI-Device Identifier: 05051986011165
• UDI-Public: 05051986011165
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 03/14/2021
• Device Model Number: 120-7800
• Device Catalogue Number: 120-7800
• Device Lot Number: 708338
• 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: 06/17/2016
• 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