MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*5MM CURVED SCISSORS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	5DCS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 7/9/2025.D4 batch #a97h1e.B3: only event year known: 2025.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 determined that the 5dcs device was returned with no damage in the external components.The instrument was mechanically tested in order to evaluate the reported incident and during the analysis, it was noted that the tip of the jaws was misalignment causing the difficulty to close and open the trigger.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿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 reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch a97h1e number, and no non-conformances were identified.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: what is meant by "the product would pop open"? was there any damage to the device? was there any damage to the jaw? was there any damage to the handle? if other, please specify.
Event or Problem Description
It was reported that the facility received boxes of product for a trial and upon using the product they would pop open.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/29/2025 d4: batch # a97h1e investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 5dcs device was returned with no damage in the external components.The instrument was mechanically tested in order to evaluate the reported incident and during the analysis, it was noted that the tip of the jaws was misalignment causing the difficulty to close and open the trigger.As part of ethicon¿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 reported complaint was confirmed.Device history review a manufacturing record evaluation was performed for the finished device batch a97h1e number, and no non-conformances were identified.

• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 22456856
• Report Number: 3005075853-2025-05297
• Device Sequence Number: 8280394
• Product Code: GEI
• UDI-Device Identifier: 10705036000785
• UDI-Public: (01)10705036000785(17)300131(10)A97H1E
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 5DCS
• Device Lot Number: A97H1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Patient Sex: Unknown