MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	D11LT
Medical Device Problem Codes	Component Missing (2306); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
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-conformances were identified.Attempts are being made to obtain the following information and the device.To date, no response has been provided and no device received.If the device or further details are received at a later date, a supplemental medwatch will be sent: was the outer seal noted to be missing when packaging was opened? 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
It was reported that during a laparoscopy procedure, it was observed in the trocar that the fitting piece above the unidirectional valve was missing.The product was replaced and did not cause any harm to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2021.H6: component code = g04.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the d11lt device was returned with the sleeve and obturator with no apparent damage and the universal seal assembly was missing.In addition, the tyvek was returned along with the device.No conclusion could be reached as to how the universal seal became missing due to the package was received open.No functional test could be performed due to the condition of the device.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The event described is confirmed and although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: please note that the outer seal can be removed by pushing the outer seal release lever in a counterclockwise direction and lifting off the outer seal.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10636167
• Report Number: 3005075853-2020-05163
• Device Sequence Number: 2901042
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: 10705036001560
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 11/30/2024
• Device Model Number: D11LT
• Device Catalogue Number: D11LT
• Device Lot Number: U40033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1
• Patient Age: 69 YR