MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. FLEXIPATH*SURG TROCAR 15MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	FP015
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/24/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.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.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 unknown procedure, a 15mm trocar was marked as 15mm but the sleeve was marked as 20 mm.There were no adverse consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/21/2023.D4: batch # unknown.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 revealed that the fp015 device was returned inside it's original packaging unopened.Upon visual inspection, a sleeve of 20mm was observed to be inside the package of 15mm sleeve.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• 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: 17612542
• Report Number: 3005075853-2023-06040
• Device Sequence Number: 7399532
• Product Code: GCJ
• UDI-Device Identifier: 10705036011910
• UDI-Public: 10705036011910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931111
• 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): 09/21/2023

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: FP015
• Device Lot Number: A9C73V
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown