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)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: were the jaws of the device broken off (was the end effector broken off)? or was the plastic coating/insulation peeled off of the shaft of the device and it fell into the patient's abdomen? was the "black plastic tip" retrieved from the patient's abdomen? was there any patient consequence? the plastic coating/insulation peeled off of the shaft and fell into the patient¿s abdomen.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the piece retrieved from the patient¿s abdomen?.
Event or Problem Description
During the extraction of the device was recognized that a 2 cm black plastic tip was in the abdomen.The tip is broken.
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.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was the piece retrieved from the patient¿s abdomen? yes.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was the piece retrieved from the patient¿s abdomen? yes.

• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7292807
• Report Number: 3005075853-2018-08162
• Device Sequence Number: 1354913
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 04/12/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 02/26/2018; 04/13/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown