MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number EPS03

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 laparoscopic hysterectomy, the shaft was bent, and the electrode came out from the shaft when pulling in/out the electrode.No pieces fell into the patient.The device was used on ligament.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 2/27/2023.D4 batch #: x95r38.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with the electrode tip bent and the shaft sheath damaged at the instrument tip.In addition, the electrode was not detached as reported.A bent electrode could have caused this damage to the sheath.Caution should be taken not to retract the electrode into the sheath when it is bent.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what could have caused the electrode tip damage, the instructions for use contain the following caution: do not attempt to bend, sharpen, or otherwise alter the shape of the electrode tip.Doing so may cause electrode tip failure and user or patient injury.Please reference the instruction for use for more information.

• 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: 16263783
• MDR Text Key: 308967977
• Report Number: 3005075853-2023-00620
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012474
• UDI-Public: 10705036012474
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912492
• 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
• Report Date: 01/30/2023

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: EPS03
• Device Catalogue Number: EPS03
• Device Lot Number: X95R38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.