FDA Adverse Event Malfunction Summary report: N

JAW INS.BIP.MARYLAND DISS.FEN.5/310MM

MDR report key: 5021094 · Received August 13, 2015

Report

Report Number: 2916714-2015-00694
Event Type: Malfunction
Date Received: August 13, 2015
Date of Event: May 8, 2015
Report Date: August 13, 2015
Manufacturer: AESCULAP AG & CO. KG
Product Code: GEI
PMA / PMN Number: NARRATIVE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

510 (K); K001330 / K003608. US REPORTING AGENT NOTIFIED ON (B)(4) 2015. MANUFACTURING SITE EVAL: THE CERAMIC OF THE INSTRUMENT IS BROKEN IN SEVERAL AREAS. THE BROKEN FRAGMENTS ARE NOT AVAILABLE FOR INVESTIGATION. THE MECHANICAL FUNCTION OF THE INSTRUMENT IS ACCORDING TO SPEC. THE INSTRUMENT WAS ANALYZED BY MICROSCOPE. THE POINTS OF BREAKAGE EXHIBIT NO UNUSUAL STRUCTURAL CONDITIONS, NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILED REVIEWED AND FOUND TO BE ACCORDING TO SPEC VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. BASED ON THE INFORMATION AVAILABLE AS WELL AS THE RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLE USER RELATED. THIS KIND OF INSTRUMENTS IS DESIGNED FOR DELICATE USE ONLY. IT IS LIABLE A MECHANICAL OVERLOAD SITUATION OR A DROP LED TO THE BREAKAGE. CORRECTIVE/PREVENTIVE ACTION: NOT APPLICABLE.

Description of Event or Problem · 1

COUNTRY OF COMPLAINT: (B)(6). CERAMIC BROKE; POSSIBILITY OF REMAINED FRAGMENTS IN PATIENT. COMPONENTS IN USE: PM973R / INSULATED OUTER TUBE 5/5MM 310MM. PM450R / HANDLE FOR BIPOLAR INSTRUMENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
535757	JAW INS.BIP.MARYLAND DISS.FEN.5/310MM	BIPOLAR FORCEP	GEI	AESCULAP AG & CO. KG	PM438R	61951069

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other