FDA Adverse Event Malfunction Summary report: N

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

MDR report key: 5644047 · Received May 10, 2016

Report

Report Number: 2916714-2016-00360
Event Type: Malfunction
Date Received: May 10, 2016
Date of Event: April 8, 2016
Report Date: October 18, 2017
Manufacturer: AESCULAP AG
Product Code: GEI
PMA / PMN Number: K001330
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. ADDITIONAL INFORMATION: ADDITIONAL PRODUCT CODE HGI AND ADDITIONAL 510K CODE K003608. H3 OTHER TEXT: DEVICE NOT RETURNED.

Description of Event or Problem · 0

COUNTRY OF COMPLAINT: JAPAN. DURING AN OPERATION, THE JAW (MATERIAL: STAINLESS) WAS BROKEN. ACCORDING TO THE SURGEON, THE FRAGMENT WAS STILL IN THE PATIENT'S BODY. THE SURGEON IS STILL DISCUSSING IF THE FRAGMENT IS NEEDED TO BE TAKEN OUT OR NOT.

Additional Manufacturer Narrative · 1

INVESTIGATION: NO PRODUCT AT HAND. THERE WAS A VISUAL INSPECTION OF THE MATERIAL USING PROVIDED PHOTOS. WE FOUND VISIBLY DAMAGED BLUE CERAMIC. ON THE OTHER SIDE THE CERAMIC IS BROKEN AND ON THE OTHER SIDE THERE IS A BROKEN OFF AREA. FURTHERMORE WE FOUND A VISIBLY DAMAGED GREY CERAMIC. THE BROKEN OFF FRAGMENT SHOWS SIGNS OF DISCOLORATION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: WE ASSUME A MECHANICAL OVERLOAD SITUATION AS THE CAUSAL FACTOR. THERE IS THE POSSIBILITY OF TORSION OR HIGH LEVERAGE WITH THE INSTRUMENT. ACCORDING TO THE QUALITY STANDARD A PRODUCTION ERROR AND A MATERIAL DEFECT CAN BE EXCLUDED. NO CAPA IS NECESSARY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298076	JAW INS.BIP.MARYLAND DISS.FEN.5/310MM	ENDOSCOPY	GEI	AESCULAP AG	PM438R

Patients

Seq	Age	Sex	Outcome	Treatment
1