MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_FLEXIPATH* FLEXIBLE SURGICAL TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number UNK_FLEXIPATH* FLEXIBLE SURGIC

Device Problem Crack (1135)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that during a gastric sleeve procedure, trocar cracked in half upon insertion.Pieces were successfully removed from patient.No patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 1/10/2024.D4: batch # unk.Per user facility medwatch form, #mw5147696.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 1/10/2024.

• Type of Device: LAPAROSCOPE, GENERAL & 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: 18486985
• MDR Text Key: 332577154
• Report Number: 3005075853-2024-00264
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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: UNK_FLEXIPATH* FLEXIBLE SURGIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1