Model Number DGP-PMC-25 |
Device Problem
No Apparent Adverse Event (3189)
|
Patient Problem
Burn(s) (1757)
|
Event Date 06/14/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will not be returned to bsn because it was discarded by the facility.
|
|
Event Description
|
A report was received that a patient was burned on the calf by a grounding pad during a cervical rf procedure.Two grounding pads were used.The first pad was placed on the right leg and the patient experienced pain with stimulation, the physician repositioned the pad, but the pain in the right leg was a size of a thumbnail and persisted.Another grounding pad was used on the left leg and the patient developed redness and a burn.The operating room staff confirmed the grounding pads were applied directly to the skin with no barriers between the skin and the grounding pad.The burn was noted as a first degree burn.The patient did not receive medical treatment for the burn.
|
|
Manufacturer Narrative
|
Additional information was received stating that the physician was concerned that the device was malfunctioning.
|
|
Event Description
|
A report was received that a patient was burned on the calf by a grounding pad during a cervical rf procedure.Two grounding pads were used.The first pad was placed on the right leg and the patient experienced pain with stimulation, the physician repositioned the pad, but the pain in the right leg was a size of a thumbnail and persisted.Another grounding pad was used on the left leg and the patient developed redness and a burn.The operating room staff confirmed the grounding pads were applied directly to the skin with no barriers between the skin and the grounding pad.The burn was noted as a first degree burn.The patient did not receive medical treatment for the burn.
|
|
Manufacturer Narrative
|
A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
|
|
Event Description
|
A report was received that a patient was burned on the calf by a grounding pad during a cervical rf procedure.Two grounding pads were used.The first pad was placed on the right leg and the patient experienced pain with stimulation, the physician repositioned the pad, but the pain in the right leg was a size of a thumbnail and persisted.Another grounding pad was used on the left leg and the patient developed redness and a burn.The operating room staff confirmed the grounding pads were applied directly to the skin with no barriers between the skin and the grounding pad.The burn was noted as a first degree burn.The patient did not receive medical treatment for the burn.
|
|
Manufacturer Narrative
|
Additional suspect medical device components involved: model #: cb105 lot #: j481 description: reference cable, for dgp-pmc cordless ground pad model #: g4 serial # (b)(4) description: g4 cosman radiofrequency generator device analysis was performed on the returned cable and the device passed all tests performed.Device analysis was performed on the returned g4 generator and the device passed multiple tests performed.The complaint of the patient being burnt from the grounding pad could not be reproduced.Visual inspection noted multiple paint chips on the cover due to external mechanical force.
|
|
Event Description
|
A report was received that a patient was burned on the calf by a grounding pad during a cervical rf procedure.Two grounding pads were used.The first pad was placed on the right leg and the patient experienced pain with stimulation, the physician repositioned the pad, but the pain in the right leg was a size of a thumbnail and persisted.Another grounding pad was used on the left leg and the patient developed redness and a burn.The operating room staff confirmed the grounding pads were applied directly to the skin with no barriers between the skin and the grounding pad.The burn was noted as a first degree burn.The patient did not receive medical treatment for the burn.
|
|
Manufacturer Narrative
|
Additional suspect medical device components involved: model #: cb105 lot #: j481 description: reference cable, for dgp-pmc cordless ground pad model #: g4 serial # (b)(4) description: g4 cosman radiofrequency generator device analysis was performed on the returned cable and the device passed all tests performed.Device analysis was performed on the returned g4 generator and the device passed multiple tests performed.The complaint of the patient being burnt from the grounding pad could not be reproduced.Visual inspection noted multiple paint chips on the cover due to external mechanical force.
|
|
Event Description
|
A report was received that a patient was burned on the calf by a grounding pad during a cervical rf procedure.Two grounding pads were used.The first pad was placed on the right leg and the patient experienced pain with stimulation, the physician repositioned the pad, but the pain in the right leg was a size of a thumbnail and persisted.Another grounding pad was used on the left leg and the patient developed redness and a burn.The operating room staff confirmed the grounding pads were applied directly to the skin with no barriers between the skin and the grounding pad.The burn was noted as a first degree burn.The patient did not receive medical treatment for the burn.
|
|
Search Alerts/Recalls
|