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

Model Number	EPS04
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	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: the broken piece was stuck on specimen which has been already taken out.The broken piece was discarded.Surgeon's comment: the device was used to suction under the robot assisted surgery.The device was use only a little, and it is not sure when it broke.This was the first experience of this kind of the issue, although i had been used pp2 for many times.I knew it was made by very hard tissue, it surprised me that the device broke like this time.·the patient is stable.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.
Event or Problem Description
It was reported that, during a laparoscopic oophorectomy, it was found that the device tip was broken during use.The broken piece was found.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4) date sent: 10/29/2021 investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the eps04 device was received with the shaft sheath damaged at the instrument tip.In addition, the electrode tip is present and not detached as reported the instrument was tested for continuity and was found to be conforming.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: do not attempt to bend, sharpen, or otherwise alter the shape of the shaft sheath.Doing so may cause electrode tip failure and user or patient injury.Please reference the instruction for use for more information.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12506169
• Report Number: 3005075853-2021-05603
• Device Sequence Number: 3375873
• Product Code: GCJ
• UDI-Device Identifier: 10705036012481
• UDI-Public: 10705036012481
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: No Information
• Device Expiration Date: 07/31/2025
• Device Model Number: EPS04
• Device Catalogue Number: EPS04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/29/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; GENERATOR