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

Catalog Number	EPS03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/22/2025 d4 batch #: a97f5d investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with the distal side of the shaft sheath damaged with a cut.In addition , a piece from the sheath was returned in a plastic bag.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.Additionally, we received photos by the costumer.The image labeled "c2" shows two pieces of the sheath, while the image named "img_0673" depicts the package along with the plastic bag with the pieces inside.Due to this condition the event reported was confirmed.A manufacturing record evaluation was performed for the finished device 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 this damage.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/8/2025.B3: unknown; captured as awareness date.D4 batch #: unknown.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: did the patient experience any adverse consequences due to this issue? 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 or Problem Description
It was reported that, during laparoscopic ovarian cystectomy, around the end of the procedure, it was found that there was a breakage to the tip of esp03.The most part of the breakage was found since it was attached to surgical drape.However, it was difficult to think that all the pieces were collected, and they weren¿t collected other outside of the body, so the hospital washed and sucked inside of the abdominal cavity carefully.It was still unknown whether other small pieces could be collected or not.The thing that could be received was only a shaft, not an eph handle.The pieces which could be collected were also received.The same device was used as is to complete the case.No further information is available.

• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22750119
• Report Number: 3005075853-2025-06316
• Device Sequence Number: 18321848
• Product Code: GCJ
• UDI-Device Identifier: 10705036012474
• UDI-Public: (01)10705036012474(17)300131(10)A97H2K
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: EPS03
• Device Lot Number: A97H2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown