MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*BLUNT TIP DISSECTOR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	BTD05
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/6/2025.D4: batch # unk.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 btd05 device was returned outside it's package opened.Upon visual inspection, a damaged was noted to be one of the three dissectors.No conclusion could be reached as to what may have caused the reported incident.The complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot 237d68 number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown surgery, there were scratches on the handle when checked the device before use.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21540560
• Report Number: 3005075853-2025-01840
• Device Sequence Number: 8050447
• Product Code: MDM
• UDI-Device Identifier: 10705036011873
• UDI-Public: (01)10705036011873(17)290731(10)237D68
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: BTD05
• Device Lot Number: 237D68
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown