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

Catalog Number B12SRT

Device Problems Component or Accessory Incompatibility (2897); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy, the surgeon tried to use the device but inner cylinder could not be removed.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 2/22/2024.D4: batch # a9dm1w.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 a b12srt device was returned with the obturator inserted through the sleeve.In addition, the tyvek was returned along with the instrument.Upon evaluation of the device, the obturator cap was found slightly separated not allowing the latch to release from the universal seal and the cam lock non functional.No conclusion could be reached regarding what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 3/28/2024.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: 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 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18762848
• MDR Text Key: 336962136
• Report Number: 3005075853-2024-01560
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: B12SRT
• Device Lot Number: 586C05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1