MAUDE Adverse Event Report: XOMED MICROFRANCE MFG MICROFRANCE® INSTRUMENT; FORCEPS, ENT

Model Number MCL-S22

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

It was reported that ¿the jaw of the forceps was broken,¿ a back-up device was used to complete the procedure; there was no patient involvement.It has been clarified that the ¿¿sl¿ part was fallen out from the device.¿.

Manufacturer Narrative

(b)(4).This device is used for therapeutic purposes.Concomitant device: mcl-s21: forceps mcl-s21 right sataloff heart, lot 200901mf4 manufactured: january 2009.(b)(4): product evaluation: no analysis available; device not received for evaluation.Method: no testing methods performed.(b)(4).

Manufacturer Narrative

Model #: mcl-s22.Device available for evaluation? yes returned to manufacturer: january 29, 2015.Date received by manufacturer: february 2, 2015 h3: product evaluation: analysis for mcl-s21, lot 090104mf3, found that the active part of the instrument is broken.The pin between the jaws did not resist.The tube is bent and there are impacts on the jaws.All the parts are still on the instrument.There is no risk of fragment in the patient.No material or manufacturing defect was found.The most probable cause of this breakage is an excessive effort during the use or the reprocessing of the instrument.Analysis for mcl-s22, lot 110903mf4, found that the clevis that holds the jaws is broken.The tube is bent.There are impacts on the jaws.However, there is no missing part; there is no risk of fragment in the patient.No material or manufacturing defect was found.The most probable cause of this breakage is an excessive effort during the use or the reprocessing of the instrument.(b)(4).

Manufacturer Narrative

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

• Brand Name: MICROFRANCE® INSTRUMENT
• Type of Device: FORCEPS, ENT
• 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: 4475752
• MDR Text Key: 5499270
• Report Number: 9680837-2015-00014
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCL-S22
• Device Catalogue Number: MCLS22
• Device Lot Number: 201109MF3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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