MAUDE Adverse Event Report: GIMMI GMBH GIMMI GMBH; ALPHADUR MONOPOLAR LAP L-HOOK

Model Number	T.0120.62
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to user facility report no.Mw5103785 the event was describes as follows: the trocar is a metal trocar, and a l-hook was inserted through it and used as an electrocautery.The insulation coating on the l-hook became overheated and was burned.No flames were seen, but you can see charging on the inside of the trocar mouth and you can see where the insulation was charred and peeled on the l-hook.The or team noticed little pieces of charging on the device along with charred flecks.The physician promptly removed the device when he noticed this and irrigated.When he pulled the metal trocar out, he noticed a small (about 1cm) burn on the patient's skin at the trocar insertion site.The procedure was a lap cholecystectomy., fda safety report id # (b)(4); mw5103785.

• Brand Name: GIMMI GMBH
• Common Device Name: ALPHADUR MONOPOLAR LAP L-HOOK
• Manufacturer (Section D): GIMMI GMBH; carl-zeiss-str. 6; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• MDR Report Key: 12681875
• Report Number: 9612074-2021-00001
• Device Sequence Number: 20391625
• Product Code: GEI
• UDI-Device Identifier: 04049047640868
• UDI-Public: 04049047640868
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K012660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T.0120.62
• Device Catalogue Number: LAP-2021
• Device Lot Number: 44204210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other