FDA Adverse Event Malfunction Summary report: N

BIPOLAR INSERT CEV634-1A 350MM MOUIEL [MXI/XOM]

MDR report key: 3723678 · Received April 3, 2014

Report

Report Number: 9680837-2014-00024
Event Type: Malfunction
Date Received: April 3, 2014
Date of Event: March 11, 2014
Report Date: March 17, 2014
Manufacturer: XOMED MICROFRANCE MFG
Product Code: GEI
PMA / PMN Number: K993655
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICE: (B)(4): BIPOLAR INSERT (B)(4) 350MM MOUIEL, LOT 130911, MANUFACTURED SEPTEMBER 2013, 510K: K993655. (B)(4). PRODUCT EVALUATION: ANALYSIS ON (B)(4), (LOT 130714), FOUND THAT THE INSERT IS ON SHORT CIRCUIT. THE COATING (INSULATION) IS STRONGLY DAMAGED AND SHOWS LONGITUDINAL SCRATCHING TRACES. THE DEVICE FAILED ELECTRICAL TESTS. THE MOST PROBABLE CAUSE OF THE COATING DAMAGES ON THE INSERT IS A SHOCK OR AN EXCESSIVE ABRASION DURING THE USE OR THE REPROCESSING OF THE INSERTS. ANALYSIS OF (B)(4) (LOT 130911) FOUND THAT THE ELECTRODE IS ON SHORT CIRCUIT. WE DID NOT HIGHLIGHT ANY SURFACE DEFECTS. THE DEVICE FAILED ELECTRICAL TESTS. THE ORIGIN OF THE FAULT CANNOT BE DETERMINED. MULTIPLES CAUSES ARE POSSIBLE (FACTORY DEFECT /ABNORMAL USE).

Description of Event or Problem · 1

THE DEVICE WAS RETURNED WITH A REQUEST ¿TO BE TESTED¿. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND INSULATION DAMAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
200937	BIPOLAR INSERT CEV634-1A 350MM MOUIEL [MXI/XOM]	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	XOMED MICROFRANCE MFG	CEV634-1A	130714

Patients

Seq	Age	Sex	Outcome	Treatment
1