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

Catalog Number B12LT

Device Problem Crack (1135)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 11/22/2023.D4 batch #: unknown.Additional information was requested and the following was obtained: could you please specify how the device was damaged, was the sleeve damaged? -sleeve tip broken was the housing d.Amaged? -no.Was there any insufflation issue? -no.Was there any seal damaged? -no.Any visible broken part? -yes, the broken part has been found and removed.Is the current patient status known? -unknown.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).-no.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.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.

Event Description

It was reported that during an unknown procedure a puncture device was used.When the chest cavity was closed, it was found to be damaged.Once the puncture device was found to be damaged, it was immediately reported to the chief surgeon, department director, and head nurse who arrived at the surgical site.After searching the chest cavity again, damaged instruments were found in the incision tissue and all were removed.After reassembling, they were intact and correct.

• 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 ; * 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: 18191563
• MDR Text Key: 328980219
• Report Number: 3005075853-2023-08680
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• UDI-Public: 10705036001164
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2023

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 Catalogue Number: B12LT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male