MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 5MM XCEL STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number CB5ST

Device Problems Crack (1135); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2023

Event Type  Injury  

Event Description

It was reported that during an ob-gyn procedure, the forceps hit the trocar when taking out the forceps through the trocar, and the tip of the trocar broke.There is a possibility that the broken part was left into the patient.Another device was used to complete the case.

Manufacturer Narrative

(b)(4) batch # unknown.Additional information was requested and the following was obtained: "this file was reviewed by a cross functional team during the weekly ae review on march 22, 2023, and additional information was requested: was the forceps device monopolar or manual forceps? => manual forceps.Does surgeon believe a piece remains in patient? => the lack of the sleeve was suspected.What steps were taken to locate the broken piece? => no procedure change was required to retrieve the piece.Are there any plans to remove the broken piece? => no.What action was being performed when the trocar broke? => the sales rep tried to get the information but the detailed information was not provided.In what anatomical location was the trocar when the breakage occurred? => the trocar was used for the total laparoscopic hysterectomy.Was there excessive torquing of the instrument at the time of the breakage? => the sales rep tried to get the information but the detailed information was not provided.What is the approximate the shape and size of the broke piece? => sukagawa qa team checked this device the damaged area was seemed to be rided up.Does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? => no.Was there any change to the procedure or post op care of patient as result of trocar breakage? if so, please explain.=> no.What is the current patient status? => the patient is stable.".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 cb5st device was received with the tip of the sleeve broken.In addition, a piece of plastic from the sleeve was returned inside a petri dish.No conclusion could be reached regarding what may have caused the reported incident.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.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The manufacturing records could not be reviewed as the batch number is unknown.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.

• Brand Name: 5MM XCEL STABILITY SLEEVE
• Type of Device: 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: 16714826
• MDR Text Key: 313070405
• Report Number: 3005075853-2023-02479
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001355
• UDI-Public: 10705036001355
• 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
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CB5ST
• Device Catalogue Number: CB5ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other