FDA Adverse Event Malfunction Summary report: N

COLIBRI

MDR report key: 2873924 · Received December 14, 2012

Report

Report Number: 8030965-2012-01580
Event Type: Malfunction
Date Received: December 14, 2012
Report Date: November 15, 2012
Manufacturer: SYNTHES GMBH
Product Code: GFA
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

(B)(4). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(4): PLACEHOLDER.

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT CODES: DZI, ERL, HBE. THE INVESTIGATION HAS SHOWN THAT THE COLIBRI HANDPIECE STARTS RUNNING AS SOON AS THE BATTERY IS INSERTED. THE HANDPIECE HAS BEEN DISMANTLED AND CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS. THE INSPECTION HAS SHOWN THAT THERE IS A SHORT CIRCUIT IN THE ELECTRONICS. UNFORTUNATELY, THE EXACT CAUSE OF THIS FAILURE COULD NOT BE DETERMINED; A POSSIBLE REASON COULD BE AN OVERLOAD, EXCESSIVE TEMPERATURE OR AGING OF THE SYSTEM. CHECKING THE SALES DATA AND REVIEWING THE PRODUCTION HISTORY THE OCCURRENCE RATE HAS BEEN DEFINED AS (B)(4) AND AT THE MOMENT, NO FURTHER ACTIONS WILL BE TAKEN.

Description of Event or Problem · 1

A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN THE (B)(6) REPORTED: HANDPIECE STARTS RUNNING WITHOUT TOUCHING. HANDPIECE STARTS RUNNING AS SOON AS THE BATTERY IS INSERTED, WITHOUT TOUCHING THE TRIGGERS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLIBRI	COLIBRI	GFA	SYNTHES GMBH		5987

Patients

Seq	Age	Sex	Outcome	Treatment
1