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

Model Number B12LTH

Device Problem Material Integrity Problem (2978)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, a part of the rubber valve broke and this plastic part ended up in the patient¿s abdomen.The plastic was recovered.

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed first day of month that complaint was reported.Batch # unk.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 there any patient consequences? if yes, please describe." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 5/10/2023.D4: batch # unk.Investigation summary : the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that only the universal seal from the b12lth device and a piece of seal were returned inside a plastic bag.The universal seal was disassembled in order to evaluate the condition of the seals.Upon disassembling, the seal was found damaged and torn.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." as part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2023.Additional information was requested and the following was obtained: "were there any patient consequences? if yes, please describe.No consequence".

• 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: 16539375
• MDR Text Key: 311262031
• Report Number: 3005075853-2023-01542
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001171
• UDI-Public: 10705036001171
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/10/2023

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 Model Number: B12LTH
• Device Catalogue Number: B12LTH
• Device Lot Number: 944A46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 03/17/2023; 04/19/2023
• Supplement Dates FDA Received: 04/11/2023; 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1