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

Catalog Number	5600100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was discarded and not available for evaluation.A cause of the detached insulation cannot be determined at this time.The investigation is currently ongoing.A supplemental mdr will be submitted when the evaluation is completed.Device was not returned.
Event or Problem Description
It was reported per the user facility that the black coating on the disposable needle point cautery tips fell off.Contact confirmed that a piece detached when cleaning the tip, and there is concern this could result in the piece falling off during use.There was no reported patient injury/complication as a result of the problem experienced.
Additional Manufacturer Narrative
The subject product was discarded and not available for evaluation.A cause of the detached insulation cannot be determined at this time.The investigation is currently ongoing.A supplemental mdr will be submitted when the evaluation is completed.This is an addendum to the initial emdr to document that the initial report contained erroneous information.The user facility has confirmed that there was no failure associated with this electrosurgical device.
Event or Problem Description
It was reported per the user facility that the black coating on the disposable needle point cautery tips fell off.Contact confirmed that a piece detached when cleaning the tip, and there is concern this could result in the piece falling off during use.There was no reported patient injury/complication as a result of the problem experienced.Addendum: information provided during follow up with user facility found that this complaint was opened based on erroneous information.The user facility confirmed there was no failure that occurred associated with the electrosurgical tip (5600100) as was previously reported.

• Brand Name: ELECTROSURGICAL TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8637133
• Report Number: 1213643-2019-04252
• Device Sequence Number: 11260574
• Product Code: GEI
• UDI-Device Identifier: 00801741077180
• UDI-Public: (01)00801741077180
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Expiration Date: 05/28/2024
• Device Catalogue Number: 5600100
• Device Lot Number: DADRAT04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1