MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. ELECTROSURGICAL TIP; ELECTROSUGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	5600160
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three photos from the procedure were returned.The first photo appears to show a reddish tissue that may be a photo of the alleged liver burn.No instruments are shown in the image.The next two photos show that cauterization was performed or being performed.In the last image the l-hook tip is visible along with another metal surgical tool.It is unknown if this secondary tool was being used at the time of the reported arcing of the l-hook tip.As reported no other devices were being used.The subject product was returned and a preliminary evaluation was performed.The tip, tip insulation and sheath were found intact with no damage or melting noted.The subject product was sent to the manufacturer for further evaluation.Based on the preliminary evaluation, no definitive conclusion can be made at this time.A supplemental mdr will be sent when the evaluation has been completed.As reported through a follow up with the user facility, the patient required no medical intervention.The ifu for this product states the necessary warnings to minimize electrosurgical risks and warn for the potential for capacitive coupling and inadvertent burning to the patient.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
Information as reported by the maude report (mw5068097): surgeon experienced l hook device uncontrolled "arcing" during a laparoscopic procedure.This caused an incidental burn of the liver when cauterizing the gall bladder.Additional information as reported by the user facility: during use of a disposable l-hook electrosurgical electrode in a laparoscopic procedure, the device arced.This caused an incidental burn of the liver when cauterizing the gall bladder.The device was not being used with any other devices and there was no damage noted to the outer sheath.The patient did not require medical intervention as a result of the event.The device was used to complete the procedure.
Additional Manufacturer Narrative
This is an addendum to the initial mdr as the sample evaluation has been completed.The tip and sheath on the subject product appeared new and no melting, markings, or blemishes were found to the insulated area.The tip looked in good condition, no marks were noted on the metal tip.The device history record was reviewed and all indications confirm proper insulation and coverage of the inner tip area and sheath confirm to procurement specifications.Conformance was indicated throughout the process router.Products are tested 100% for electrical testing phases during production.This has been the first reported complaint for the subject lot of (b)(4) units manufactured in june of 2016.The ifu for this product states the necessary warnings to minimize electrosurgical risks and warn for the potential for capacitive coupling and inadvertent burning to the patient.While it was reported that the device was not being used with any other devices, the photo provided by the user facility shows the l-hook tip visible along with another metal surgical tool.At this time, no definitive conclusion can be made.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: ELECTROSURGICAL TIP
• Common Device Name: ELECTROSUGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6471341
• Report Number: 1213643-2017-00217
• Device Sequence Number: 364607
• Product Code: GEI
• UDI-Device Identifier: 00801741077203
• UDI-Public: (01)00801741077203(17)210628(10)DAATAT26
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K010444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 5600160
• Device Lot Number: DAATAT26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 04/25/2017
• 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
• Patient Age: 39 YR