FDA Adverse Event Malfunction Summary report: N

CAIMAN DISP INSTR ARTICULAT D:12/240MM

MDR report key: 3805223 · Received April 16, 2014

Report

Report Number: 2916714-2014-00247
Event Type: Malfunction
Date Received: April 16, 2014
Report Date: April 16, 2014
Manufacturer: AESCULAP AG & CO KG
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

K093075/K130596. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: VISUAL INSPECTION - BOTH INSTRUMENTS ARRIVED PACKED COMMONLY IN THE ORIGINAL BOX. WITH THE FIRST VIEW IT WAS NOTICED THAT THE INSTRUMENTS HAVE BEEN DECONTAMINATED. NO SIGNS OF MECHANICAL DAMAGE PRESENT. ELECTRICAL AND MECHANICAL PARAMETERS WERE EVALUATED AND FOUND TO BE ACCORDING TO PRODUCT SPEC. CONCLUSION: ALL INDICATIONS ARE THAT THE FAILURE IS RELATED TO AN APPLICATION ERROR, THERE NO HINTS FOR A PRODUCT FAULT OR MATERIAL DEFECT. WITH PRODUCT BEING DECONTAMINATED PRIOR TO EVAL, IT CAN NOT BE DETERMINED IF CONTAMINATION PLAYED A ROLE IN THE FAILURE NOTED. THERE ARE CURRENTLY NO FURTHER COMPLAINTS WITH BATCH S478 AT HAND.

Description of Event or Problem · 1

COUNTRY OF COMPLAINT: (B)(6). LOTS OF BLEEDING DURING A HEMICOLECTOMY. THE FIRST 10 SEALINGS WENT VERY WELL. THE FIRST VESSEL THAT DIDN'T SEAL WAS A VESSEL IN THE OMENT. AFTER THAT ALMOST EVERY SEALING WAS BLEEDING. THE NURSE CLEANED THE JAWS, THE LEKTRAFUSE DISPLAY WAS CHECKED (READY TO SEAL) AND CONTINUED FOR ANOTHER HOUR, WITH A HIGH NUMBER OF BLEEDINGS. ANOTHER DEVICE WAS BROUGHT IN AND USED BUT THERE WAS STILL A LOT OF BLEEDING. AFTER ANOTHER HOUR THE SURGEON DECIDED TO CHANGE TO LIGATURE, NO BLEEDING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
233458	CAIMAN DISP INSTR ARTICULAT D:12/240MM	SEAL & CUT INSTRUMENTS	GEI	AESCULAP AG & CO KG	PL730SU	S478

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other