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

Catalog Number	BTD05
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the tip of the pad breaks down.Tampon unusable because there is a risk of losing the paper tip intrathoracic.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/4/2024.D4: batch # unk.Additional information was requested and the following was obtained: "the tampon only breaks down after a certain time of use.If the intervention is shorter the tampon remains whole.So, the customer do not use more than 3 tampons or 4 maximum per intervention." 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 only one (1) dissector from the btd05 devices was returned with the dissector tip damaged.No conclusion could be reached regarding what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot 936c60 number, and no non-conformances were identified.

• 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: 20845972
• Report Number: 3005075853-2024-09141
• Device Sequence Number: 20818748
• Product Code: MDM
• UDI-Device Identifier: 10705036011873
• UDI-Public: (01)10705036011873(17)290331(10)936C60
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/04/2024

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: 936C60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown