MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 12MM XCEL STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number CB12LT

Device Problem Material Integrity Problem (2978)

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

Event Date 07/14/2023

Event Type  Injury  

Event Description

It was reported that during an unknown procedure, the device lost one of its membranes in the patient cavity.May have caused a foreign body to be left in patient.

Manufacturer Narrative

(b)(4).Date sent: 8/15/2023.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).Additional information was requested and the following was obtained: "what is the surgeons experience with this device? ¿ positive, this device was used daily in all the surgeries of the institution for more than 2 years, this situation had never occurred.What is the patients bmi?- overweight patients diagnosed with bmi greater than 30 what was the anatomical position of this specific port? - patient in supine position, port placed on left midclavicular line.What was this port¿s correlation to the patient¿s ribs? - it is close to the ribs, but not in contact with them.Is it possible the trocar point made contact with the ribs upon insertion? - no.Were there any other intra op complications? - no.What action was being performed when the device broke? - inserting laparoscopy clamp.(maryland clamp) was there excessive torquing of the instrument at the time of the breakage? - normal handling that occurs in all bariatric procedures.What instruments were passed through the trocar? - laparoscopic forceps, echelon 60 stapler.(psee60a) has there been any re-operations/attempts to look for the pieces left in the patient? - there are no reoperations since there were no pieces left in the patient, the detachment was evidenced intraoperatively and it was removed, the surgery ended successfully.Did the pieces left in the patient change the post-op care?- no pieces remained in the patient, they were removed at time, before port closure, and the patient's recovery is successful.Does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? - no, everything is disposable for single use.Is the device available for return? - no, it was discarded after being removed from the patient's cavity.".

Manufacturer Narrative

(b)(4).Date sent: 8/16/2023.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "were all parts retrieved from patient? will all pieces be returned with the device? if no, were they discarded? were there any patient consequences? if yes, please describe." "what is the surgeons experience with this device? what is the patients bmi? what was the anatomical position of this specific port? what was this port¿s correlation to the patient¿s ribs? is it possible the trocar point made contact with the ribs upon insertion? were there any other intra op complications? what action was being performed when the device broke? was there excessive torquing of the instrument at the time of the breakage? what instruments were passed through the trocar? has there been any re-operations/attempts to look for the pieces left in the patient? did the pieces left in the patient change the post-op care? does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? is the device available for return?".

Manufacturer Narrative

(b)(4).Date sent: 9/13/2023.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a adverse event and is now being considered reportable to the us fda as a malfunction.B.1: is product problem.

• Brand Name: 12MM XCEL STABILITY SLEEVE
• 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: 17549950
• MDR Text Key: 321223022
• Report Number: 3005075853-2023-05782
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: 10705036001331
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CB12LT
• Device Lot Number: 339C04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 08/22/2023; 09/13/2023
• Supplement Dates FDA Received: 08/16/2023; 09/12/2023; 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR