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

Catalog Number	5600200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned and a visual evaluation was performed.The tip insulation was not present and has detached as was reported.The tip insulation that had detached was not returned with the sample.The outer sheath was removed to visualize the needle tip and there was no damage identified and no residual tip insulation material was identified.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.
Event or Problem Description
It was reported per the user facility that the black coating on the reusable needle point cautery tips is falling off after just one sterilization.Contact confirmed that a piece detached when cleaning the tip, and there is concern this could result in the piece coming off during use.There was no reported patient injury/complication as a result of the problem experienced.
Additional Manufacturer Narrative
The sample was returned and a visual evaluation was performed.The tip insulation was not present and has detached as was reported.The tip insulation that had detached was not returned with the sample.The outer sheath was removed to visualize the needle tip and there was no damage identified and no residual tip insulation material was identified.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.Addendum: the user facility reports following the ifu for cleaning and sterilization instructions.It is possible that the tip insulation was damaged during processing and/or in use; however, a definitive root cause for the reported event cannot be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification a review of the subject lot found this to be the first complaint reported for the (b)(4) units released to stock in december of 2017.Testing of two same lot samples was conducted in which the units were processed through 20 cleaning / autoclave cycles and electrical test with no problem found.There was no degradation of material or detachment of the component.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported per the user facility that the black coating on the reusable needle point cautery tips is falling off after just one sterilization.Contact confirmed that a piece detached when cleaning the tip, and there is concern this could result in the piece coming off during use.There was no reported patient injury/complication as a result of the problem experienced.Addendum: in follow up with the user facility contacts they reported the device was used in lap total hysterectomy procedure.The problem presented during first use of the device, and following the cleaning sterilization protocol of the non-sterile reusable device.The electro cautery tip was being cleared of debris by the or tech using a wet sponge.The insulation material affixed to the distal end of the device appeared to have physically cracked and split and the material came off in the sponge in two small pieces.The pieces were discarded.Staff conformed that there was nothing that fell into the body, and no patient impact as a result of the problem the was experienced.

• 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: 8633409
• Report Number: 1213643-2019-04210
• Device Sequence Number: 1655784
• Product Code: GEI
• UDI-Device Identifier: 00801741077227
• UDI-Public: (01)00801741077227
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K003674
• 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): 06/13/2019

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 Catalogue Number: 5600200
• Device Lot Number: DABYAT21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1