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

Catalog Number B5LT

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/03/2019

Event Type  Injury  

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 lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: what procedure was the device used in? na.Clarification is needed on the quantity involved.Did both b5lt¿s have the tip broken/chipped? 1 broken tip, 1 was claimed to had chipped.Were the device(s) reprocessed? no, they were from new sterile pack.Were the broken pieces found? no.Was the device inspected prior to using? no.Was the broken/chipped tip noticed while inserting the trocar as insertion should be done using the endoscope and video camera? na.What is the anatomical location were the trocar was inserted? lateral to umbilicus.What is the current patient status? na.

Event Description

It was reported that during an unknown procedure, its optical tip broke/chipped off when surgeon attempted to insert the trocar through patient's abdomen.Never encountered such an issue prior to this incident.The surgery was successfully completed.Fragments were generated.Couldn't locate the chipped parts within the abdomen/peritoneal cavity.

Manufacturer Narrative

(b)(4).Batch # t9251y.Device analysis: the analysis found that one b5lt device was returned with the tip broke in a brittle manner that is not typical of normal overloaded fracture.This type of fracture generally results from the polymer being exposed to some type of material or environment that embrittled the part.No material was able to be extracted from the trocar on device however, it is possible that the embrittling may have occurred due to the eo process after the surgery.If a polycarbonate is not fully dried prior to being exposed to an eo sterilization cycle, a chemical reaction may occur that will react with stressed region causing it to become embrittled and easily breakable it is unknown the cause of the original break that occurred in surgery, but the material fractured in a brittle manner most likely due to environmental reaction of some type that occurred to the polycarbonate.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Per photographic evaluation: upon visual inspection of two photos, the following was observed: the first photo shows an endopath inside of a plastic bag in the handle of the user from top view and the clear lens can be seen broken.The second photo shows endopath from end of device and one of clear lens can be seen broken.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

Manufacturer Narrative

(b)(4).Batch # unknown.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8840637
• MDR Text Key: 152621517
• Report Number: 3005075853-2019-20864
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Catalogue Number: B5LT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 11/07/2019
• Patient Sequence Number: 1