MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*5MM CRVD DISSECTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	5DCD
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: could you please confirm that the insulation was damaged.Could you please clarify if there were any patient consequences? please provide the status of the device as it has not been received for analysis.
Event or Problem Description
It was reported that during an unknown procedure, the product was peeling off at the stem.It is unknown how the procedure was completed.Patient consequence was not reported.

• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11346488
• Report Number: 3005075853-2021-00955
• Device Sequence Number: 14660417
• Product Code: GEI
• UDI-Device Identifier: 10705036000778
• UDI-Public: 10705036000778
• Combination Product (Y/N): N
• PMA/510(K) Number: K984240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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 Expiration Date: 09/30/2024
• Device Model Number: 5DCD
• Device Catalogue Number: 5DCD
• Device Lot Number: T40Z66
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/18/2021
• Patient Sequence Number: 1