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

Catalog Number	B5ST
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/11/2024.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: batch # unk.Additional information was requested and the following was obtained: "it was assumed that the entire trocar was removed because the enseal was stuck in the trocar.Was there any impact to the patient such as bleeding, tissue damages, or additional recession.It was heard that there was no impact on the patient.Were the trocar and the enseal damaged? since the enseal was in the bag with the trocar stuck in it and blood adhered to it, the details has not been able to be checkd, but there was no major damage." investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b5st device was received with the tip of the sleeve broken and with a nslg2c35 product code inserted through.Due to the condition of the nslg2c35 product code device mention on the (b)(4), causing the damage and unable to removed the trocar.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.The manufacturing records couldn't be reviewed as the batch number is unknown.
Event or Problem Description
It was reported that during ob-gyn procedure, enseal has been enclosed with the trocar.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20905929
• Report Number: 3005075853-2024-09423
• Device Sequence Number: 17161409
• Product Code: GCJ
• UDI-Device Identifier: 10705036001232
• UDI-Public: 10705036001232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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 Catalogue Number: B5ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown