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

Catalog Number	BTD05
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/28/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.Additional information was requested and the following was obtained: "please confirm, for the btd05, you didn¿t receive it? no.Of the packaging was incorrectly identified as bcd10? 10mm product was put in the 5mm box.For the bcd10, the packaging was incorrectly identified as btd05? no.Wrong product was put in the wrong box." investigation summary: the product was returned to ethicon for evaluation.Visual inspection were conducted on the returned device.Visual analysis of the returned sample determined that the btd05 secondary box with lot 855a31 was returned with thirteen(13) unopened packaging of product code bcd10 product code with lot 886a36.Due to the condition of the packaging opened no conclusion could be reach on the issue reported.No conclusion could be reach on the cause of the reported event as per conditions of the returned device.As part of our quality process, the manufacturing records of this lot number were reviewed, and the manufacturing standards were met prior to the release of this lot.A manufacturing record evaluation was performed for the finished device lot 855a31 number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, got the 10 ml item (bcd10) and they were supposed to get the 5ml (btd05).No patient harm/involvement.

• 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: 18409599
• Report Number: 3005075853-2023-09925
• Device Sequence Number: 14186084
• Product Code: MDM
• UDI-Device Identifier: 10705036011873
• UDI-Public: 10705036011873
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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: 855A31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown