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

Model Number	B5ST
Medical Device Problem Codes	Material Integrity Problem (2978); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a laparoscopic oophorectomy, an unexpected sound was heard during use.When the inside of the housing was checked, it was found that the valve was not closed at all.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2022.D4: batch # v95u6r.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Upon visual analysis of the returned sample, it was determined the b5st device was returned with the obturator inserted through the sleeve and no apparent damage.In an attempt to replicate the reported incident, the device was functionally tested to detect any leaking issues and noises.Upon evaluation of the device, it was functionally leak tested and passed.The device was fully functional according to the manufacturing requirements and no noise was heard.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13339383
• Report Number: 3005075853-2022-00475
• Device Sequence Number: 11778361
• 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): 02/23/2022

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 Model Number: B5ST
• Device Catalogue Number: B5ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/23/2022
• 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