MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D5LT

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Per photographic evaluation: there was no sample received for analysis.Only pictures of the sample was received for analysis.Upon visual inspection of the pictures, a damage was noted to be on the sleeve of the device.However, no conclusion could be reached as to the origin of the damage as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported the device was requested to the pharmacy, in the service of surgery.It was detected, when removing it from the package, that the tip of the device was fractured.

• Brand Name: ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 6890393
• MDR Text Key: 87474174
• Report Number: 3005075853-2017-05119
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: D5LT
• Device Lot Number: P4R165
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2017
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR