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

Model Number	B11LPH
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, when opening the device from it's original packaging, it was seen that the "optical stop lever was missing in the spindle." it is unknown how the procedure was completed.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Batch # u9400j.(b)(4).Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b11lph device was received with the cam lock out of position and missing.In addition, only the tyvek was returned.No conclusion could be reached as to what may have caused the reported incident.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13744711
• Report Number: 3005075853-2022-01541
• Device Sequence Number: 14695065
• Product Code: GCJ
• UDI-Device Identifier: 10705036001119
• UDI-Public: 10705036001119
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2022

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: 04/30/2025
• Device Model Number: B11LPH
• Device Catalogue Number: B11LPH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown