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

Catalog Number	B11LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r92r3j.Device analysis: the analysis results found that the b11lt instrument was received with the sleeve melted.This type of damage is consistent with the one produced by an energized device.The device was visually inspected and no damaged was found on the clear lens.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
The tip of the trocar was damaged.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8241789
• Report Number: 3005075853-2019-15825
• Device Sequence Number: 2462862
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 02/28/2023
• Device Catalogue Number: B11LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1