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

Model Number	EPS01
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	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: x94w83.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 and the manufacturing criteria were met prior to the release of this lot/batch.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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 an ob-gyn procedure, a piece of what looked like the tip of the device fell off during use.The piece has been retrieved.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: 12/12/2022.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 what appears to be a few plastic flashes from the shaft in a preti dish.Additionally, the electrode tip was bent and the shaft sheath was damaged at the instrument tip.No detached electrode was observed.Additionally, the device was inspected and no missing parts were found, 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.As part of the 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 electrode tip.Doing so may cause electrode tip failure and user or patient injury.Please reference the instruction for use for more information.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/17/2022 d4 batch #: x94t6k this is an analysis of a set of images submitted to ethicon endo-surgery for evaluation.Image 1(photo a): the image provided by the customer shows a gray flash inside a petri dish.Image 2(photo b): the image provided by the customer shows damage to the shaft sheath at the electrode tip area.The electrode tip was not detached as reported.Image 3(img_7590): the image provided by the customer shows a probe handle, a probe shaft, and a petri dish.No conclusion could be reached as to how this issue occurred through photo analysis.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 like appears plastic flash from the shaft in a preti dish.Additionally, the electrode tip was bent and the shaft sheath was damaged at the instrument tip.No electrode detached was noted.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 batch number, and no non-conformances were identified.As part of the 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 electrode tip.Doing so may cause electrode tip failure and user or patient injury.Please reference the instruction for use for more information.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15671473
• Report Number: 3005075853-2022-07224
• Device Sequence Number: 6372126
• Product Code: GCJ
• UDI-Device Identifier: 10705036012450
• UDI-Public: 10705036012450
• 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,Followup
• Report Date (Section B): 10/25/2022

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 Model Number: EPS01
• Device Catalogue Number: EPS01
• Device Lot Number: X94W83
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 11/28/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/17/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown