FDA Adverse Event Malfunction Summary report: N

ELECTROSURGERY PROBE PLUS II

MDR report key: 1830283 · Received September 10, 2010

Report

Report Number: 3005075853-2010-05190
Event Type: Malfunction
Date Received: September 10, 2010
Date of Event: August 16, 2010
Report Date: August 20, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GCJ
PMA / PMN Number: K912492
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE RED PIN WAS NOT RETURNED WITH THE DEVICE. IT WAS TESTED FOR CONTINUITY AND WAS FOUND TO BE CONFORMING. NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT.

Additional Manufacturer Narrative · 1

(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THE CELL-DYN SAPPHIRE ANALYZER HAS BEEN GENERATING SHORT SAMPLE ERRORS. THE ASPIRATION BOTTOM SENSOR HAS BEEN REPLACED IN ORDER TO RESOLVE THE ISSUE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, ERROR MESSAGES WERE DISPLAYED. ONE OF THE MESSAGES WAS "DOUBLE OUTPUT POWER" (B)(4). THE OTHER ONE WAS "STOP OUTPUT POWER" (B)(4). ALTHOUGH THE DEVICE WAS NOT ACTIVATED WITH THE HAND SWITCH, THE FOOT SWITCH FUNCTIONED. THE MAIN UNIT WAS ERBE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ELECTROSURGERY PROBE PLUS II	LAPAROSCOPE, GENERAL AND PLASTIC SURGERY	GCJ	ETHICON ENDO-SURGERY, LLC.	UNK	F4R464

Patients

Seq	Age	Sex	Outcome	Treatment
1				ERBE GENERATOR