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

Catalog Number	5DCD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date of event: only event year known: 2018.Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
Insulation / tip is broken.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch #: p92t34.Device analysis: the analysis results confirmed that the 5dcd instrument was received with the shrink tube damaged and the piece of shrink tube was returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7295898
• Report Number: 3005075853-2018-08183
• Device Sequence Number: 11218522
• Product Code: GEI
• UDI-Device Identifier: 20705036000775
• UDI-Public: 20705036000775
• Combination Product (Y/N): N
• PMA/510(K) Number: K984240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 06/30/2022
• Device Catalogue Number: 5DCD
• Device Lot Number: P4RP5P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1