MAUDE Adverse Event Report: AESCULAP AG JAW INS.ALLIGATOR FORCEPS 5MM 310MM; ADTEC MONOPOLAR

Model Number PO615R

Device Problem Unintended Electrical Shock (4018)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch history review: the lot/batch/serial number of the device was unknown, therefore a batch history review cannot be performed.Clinical investigation: although there was injury to user's finger, the expectation was the injured area would fully heal and most likely not negatively affect the surgeon in the future.Product investigation: the components of the complaint sample were examined visually and with a digital microscope.Visual inspection of the insulated outer (pm973r) tube revealed groves, scratches and visible damage.Visual inspection of the metal inner tube (pm600201) showed deformed tongs.Visual inspection of the shaft (b)(6) revealed that it was bent.Investigation was also conducted on the handle (b)(6) by dissembling the device from the monopolar handle ((b)(6)); creepage and unknown deposits were observed.According to the quality standard, a material defect and production error can be ruled-out.The following test was carried-insulation test at 2400 v, 10 ma and 30 seconds.A breakdown was noted.The creepage distance was caused by a build-up of tissue and body fluids from surgery.The visible damage, deformation and bent shaft were caused by improper handling due to mechanical overload.There was also a possibility of torsion or high leverage with the device.The scratches and the grooves at the outer insulated tube were most likely caused from damage encountered with other instruments or improper handling of the device.The outer tube showed heavy signs of wear.There was a possibility for disruptive discharges if the outer tube have scratches, grooves and fine cracks.The ifu cautions the user to, "keep the product's contact surface clean during surgery.Remove encrusted tissue residues or body fluids with a moistened swab." root cause the root cause of this event was most likely attributed to usage-related.All related cases 400400560-9610612-2018-00400, 400400560-9610612-2018-00401.

Event Description

It was reported that while the device was in use, the surgeon felt a slight electric shock through the rubber gloves.The electric shock caused burns on his finger.

• Brand Name: JAW INS.ALLIGATOR FORCEPS 5MM 310MM
• Type of Device: ADTEC MONOPOLAR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP USA; 615 lambert pointe drive; hazelwood MO 63042
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7868137
• MDR Text Key: 119938740
• Report Number: 9610612-2018-00402
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K010752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO615R
• Device Catalogue Number: PO615R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Distributor Facility Aware Date: 08/22/2018
• Device Age: 4 YR
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other