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

Model Number	B11LT
Medical Device Problem Codes	Crack (1135); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Additional information was requested and the following was received: what is the patient¿s bmi? unknown.What device was in the trocar when the trocar broke? unknown.Was there any torqueing that took place when the device broke? unknown.What anatomic position was device in when it broke? unknown.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, the distal end of the trocar sleeve broke in the patient.The doctor was able to visually retrieve one piece from the abdomen but couldn't find the other piece, deciding to leave the other piece in the patient.The piece remaining was intra-abdominal and the trocar was not a reprocessed trocar.The doctor was able to complete the procedure using the existing trocar.The procedure and post-op care of patient was not altered in any way due to the retained trocar piece.There were no other patient consequences reported and the patient is ok.
Additional Manufacturer Narrative
(b)(4).Date sent:(b)(6)2020.D4: batch # t40l6k investigation summary the b11lt device was returned with the tip of the sleeve cracked/broken.An analysis was performed and the results determined that there was no evidence of the lens material being defective.The elongation and tearing of the cannula demonstrate ductile behavior and do not suggest that the material is brittle nor that there is a material defect that contributed to the damage.There were no secondary cracks observed.This type of damage could have been caused by the user applying excessive force and/or torque to the device during use and insertion of the trocar.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Device evaluation anticipated, but not yet complete.

• 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: 9905857
• Report Number: 3005075853-2020-01868
• Device Sequence Number: 2741947
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: B11LT
• Device Catalogue Number: B11LT
• Device Lot Number: T40L6K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 04/01/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/27/2020; 05/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other