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

Model Number	B5ST
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
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 retrieve the device.To date, no device has 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
It was reported that during an unknown procedure, the rubber of the trocar fell into the body.It was taken out from the patient and was discarded.Patient consequence was not reported.
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 retrieve the device.To date, no device has 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
It was reported that during an unknown procedure, the rubber of the trocar fell into the body.It was taken out from the patient and was discarded.Patient consequence was not reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/10/2022.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 b5st device was returned with no apparent damage.Upon evaluation of the device, a black plastic piece was found inside the tip of the trocar sleeve.The plastic piece was removed and a functional leak test was performed and it passed as expected.The trocar was disassembled to verify the condition of the internal components and all seals were found to be conforming without missing parts thus the received plastic piece does not belong to the device.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: the trocar is packaged with the stopcock in the open position.Close the stopcock before use.The stopcock is in the closed position when the stopcock lever is parallel to the sleeve.The event described could not be confirmed as no damages were observed and the device performed without any difficulties noted.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13564244
• Report Number: 3005075853-2022-00962
• Device Sequence Number: 17606543
• Product Code: GCJ
• UDI-Device Identifier: 10705036001232
• UDI-Public: 10705036001232
• 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,Followup
• Report Date (Section B): 08/10/2022

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: 06/17/2026
• Device Model Number: B5ST
• Device Catalogue Number: B5ST
• Device Lot Number: V95D8W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown