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

Model Number MCLS21R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It was reported that the bottom part of tip of a right, heart-shaped grasper broke intraoperatively during a direct micro laryngoscopy suspension esophagoscopy on a (b)(6), female patient, weighing (b)(6) pounds.Search for the broken tip was unsuccessful, which included a x-ray of the neck, chest and abdomen postoperatively.There was no report of permanent patient impact or injury as a result of this event.

Manufacturer Narrative

(b)(4).Method: no testing methods performed.(b)(4).This device is used for therapeutic purposes.

Manufacturer Narrative

In response to medtronic¿s request for device return, the device was returned to the manufacturer for evaluation and repair (detailed as follows): the fixed jaw is broken and the fragment was not returned.The jaws¿ thickness is compliant with the manufacturing specifications.A corroded area can be observed within the fracture zone, which suggests the presence of a crack prior to the breakage.The tube between the handle and the jaws is bent, however it has not been verified that this was part of the event and it might be due to transportation.Considering that no material or manufacturing defect was found and that there is evidence of a crack prior to the breakage, the most probable cause of this rupture is the recurrence of impacts on the instrument during its use, which weakened the jaw and progressively led to the reported event.(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: jacklyn hayman ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9042812769
• MDR Report Key: 4405326
• MDR Text Key: 16855918
• Report Number: 9680837-2015-00009
• Device Sequence Number: 1
• Product Code: KAE
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCLS21R
• Device Catalogue Number: MCLS21R
• Device Lot Number: 120901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 00059 YR
• Patient Weight: 78