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

Model Number	H12LP
Medical Device Problem Codes	Gas/Air Leak (2946); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's were identified.Attempts are being 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Hassan trocar: losing co2, seal torn, opened new device and continued procedure was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (b)(4).Device property of: none, device in possession of: none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/27/2020.D4: batch # u93068.Investigation summary: the analysis results found that the h12lp device was returned with no damage in the external components.A leak test was performed and the device was noted to leak without the test probe inserted through the device.Upon further analysis, the universal seal was noted to be damaged.No conclusion could be reached as to what might have caused the damaged on the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10141072
• Report Number: 3005075853-2020-02976
• Device Sequence Number: 2318466
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: 10705036002017
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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: 12/07/2024
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: U4008R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1