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

Model Number	B11LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information.To date, no additional information has been received.If further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that at the conclusion of an unknown procedure they noticed a piece of the black trocar diaphragm in the pelvic floor.It was retrieved and there were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/27/2021.D4: batch # v94587.Investigation summary the analysis results found that the b11lt device was returned with the seal damaged and torn.The torn pieces of the seal were returned inside a bag.The device was disassembled in order to evaluate the condition of the seal and the damage was confirmed.In addition, the separated piece of the seal was observed to have a mark which suggests that a pointy instrument was inserted through the trocar with excessive force.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." no further investigation will be conducted on this complaint due to external cause.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformances were identified.

• 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: 12443778
• Report Number: 3005075853-2021-05287
• Device Sequence Number: 3516853
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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 Model Number: B11LT
• Device Catalogue Number: B11LT
• Device Lot Number: V94587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1