MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	EPS06
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an unknown procedure the eps06's inside the package are a hook and not a spatula.They went back and opened what was needed.
Additional Manufacturer Narrative
(b)(4).Batch #: u94n9h.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection were conducted on the returned device.Visual analysis of the returned sample revealed that one eps06 device was returned inside its package unopened; upon visual inspection, the device was received with incorrect device packaged/labeling, the physical device received was an eps01 instead of eps06.As part of our quality process, the manufacturing records of this lot number was reviewed, and the manufacturing standards were met prior to the release of this lot.This defect has been correlated to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14401202
• Report Number: 3005075853-2022-03132
• Device Sequence Number: 20206139
• Product Code: GCJ
• UDI-Device Identifier: 10705036012504
• UDI-Public: 10705036012504
• Combination Product (Y/N): N
• PMA/510(K) Number: K912492
• 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): 05/13/2022

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 Expiration Date: 07/31/2025
• Device Model Number: EPS06
• Device Catalogue Number: EPS06
• Device Lot Number: U94Y4V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE
• Patient Sex: Unknown