MAUDE Adverse Event Report: XOMED MICROFRANCE MFG MICROFRANCE® GENERAL/HOSPITAL INSTRUMENTS; INSTRUMENT, ENT MANUAL SURGICAL

Model Number CP348

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

It was reported that during a septorhinoplasty case the scissors snapped at the screw where the two scissor pieces are joined and held together; the steel around the joint area snapped.The physician was able to open a different pair of scissor and complete the case without patient impact.It was confirmed that the device did break into pieces and the doctor threw the tip of the scissors into the sharps container; that piece will not be returned.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: analysis not available at this time; evaluation in progress.Method: no testing methods performed.

Manufacturer Narrative

Lot: 201108mf.Date mfr received: june 19, 2014.Device mfg date: august 2011.Product evaluation: analysis found that the blade is broken at the central screw level.The broken fragment has been recovered.The observation of the breakage zone has revealed a corroded area which indicates that a pre-existing crack was present prior the breakage.No other material defect has been observed outside this corroded zone.The instrument has probably been weakened by a pre-existing crack that has led to the observed breakage during use.The cause of the pre-existing crack is probably due to the maintenance, as the drying of the scissors in a closed position or the use of non-adapted water.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICROFRANCE® GENERAL/HOSPITAL INSTRUMENTS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): XOMED MICROFRANCE MFG; saint-aubin-le-monial; bourbon-l'archambault 3160 ; FR 3160
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3883414
• MDR Text Key: 4565712
• Report Number: 9680837-2014-00050
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CP348
• Device Catalogue Number: CP348
• Device Lot Number: 201108MF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00020 YR
• Patient Weight: 91