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)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r92a0t.Device analysis: the analysis results found that the b11lt instrument was received with the sleeve broken and melted.This type of damage is consistent with the one produced by an energized device.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.Additional information was requested and the following was obtained: did the tip of the trocar sleeve crack or break off? if yes, did any pieces of the device fall into the patient? if yes, how was the piece of the device retrieved? was there any patient consequence? if yes, please explain.It does not appear that any part of the trocar sleeve had broken off but it does look like the plastic has mishapen as if it had got hot and melted! it is not thought any pieces of the device fell into the patient.
Event or Problem Description
Misshapen tip to stability sleeve.Noted when passing the telescope through the sleeve after insertion into the patient.

• 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: 7852554
• Report Number: 3005075853-2018-12532
• Device Sequence Number: 1431715
• Product Code: GCJ
• UDI-Device Identifier: 20705036001123
• UDI-Public: 20705036001123
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 01/31/2023
• Device Catalogue Number: B11LT
• Device Lot Number: R4042U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Patient Sequence Number: 1