MAUDE Adverse Event Report: SURGICAL INNOVATIONS LIMITED LOGIC; LOGIC 355MM LONG FENESTRATED GRASPER

Model Number	101-49021
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated by a product design engineer familiar with the construction of the device who confirmed that the device was broken.The device was broken at the link mechanism and a small piece from the link mechanism of approximate size 1mm x 2mm was missing.Furthermore, the shaft of the device was observed to be bent.It was considered that the probable cause of the failure was due to wear and tear over an extended period of time and/or the device being subjected to excessive force.The device is in excess of 3 years old and the warranty period for the device is 2 years.The device history inspection record for the product assembly and packaging was reviewed and recorded as adhering to the specified requirements for final inspection and release.In addition, the assembled devices were 100% inspected prior to release.The device was manufactured in 2012, however since process improvements have been made to strengthen the device allowing greater force to be applied, while increasing the resistance to breakage.A medical opinion was also sourced from surgical innovations clinical director, prof (b)(4).Prof (b)(4) considered that if a fragment of the device was left inside the patient it is very improbable that there will be any clinical consequences.The distributor has confirmed that there was no patient harm or death.
Event or Problem Description
A distributor reported a complaint to surgical innovations.The complaint details state, the grapser has quite visibly broken.The instrument does not need repairing.All that needs to be ascertained is whether a piece of the instrument has broken off or not.The whittington are concerned that a piece of the instrument may have broken off inside the patient.

• Brand Name: LOGIC
• Common Device Name: LOGIC 355MM LONG FENESTRATED GRASPER
• Manufacturer (Section D): SURGICAL INNOVATIONS LIMITED; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• MDR Report Key: 7058675
• Report Number: 9680952-2017-00008
• Device Sequence Number: 67683
• Product Code: GEI
• UDI-Device Identifier: 05051986007182
• UDI-Public: 05051986007182
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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 Model Number: 101-49021
• Device Catalogue Number: 101-49021
• Device Lot Number: 63278
• 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: 10/16/2015
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1