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

Catalog Number	FP015
Medical Device Problem Codes	Gas/Air Leak (2946); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thoracoscopy, the obturator was not "expanding" enough to hold the black sleeve causing a loss of gas from the patient.No patient harm.
Additional Manufacturer Narrative
(b)(4) date sent: 10/19/2023 b3: unknown, assumed first day of month that complaint was reported 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 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 ; * 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: 17967206
• Report Number: 3005075853-2023-07675
• Device Sequence Number: 7623285
• 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
• Report Date (Section B): 10/19/2023

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
• Date Returned to Manufacturer: 10/02/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/19/2023
• 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