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

Model Number	EPS07
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u94g17.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the eps07 device was received with no apparent damaged and without the sterile package.Upon visual inspection to the device it was observed a white foreign matter around the rotational knob.The instrument was tested for continuity and was found to be conforming.There were no anomalies noted with the functionality of the device.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event.This is a photo analysis for a set of images submitted to ethicon endo-surgery for evaluation.Image: the images received are those who appear to be an eps07 device, seem to be spots a manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.It should be noted product failure is multifactorial.No conclusion could be reached as to how this issue occurred through photo analysis.As part of the ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that, before a laparoscopic hysterectomy, it was found that the foreign matter like a white powder was on/around the rotate knob after the package was opened.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11615143
• Report Number: 3005075853-2021-01597
• Device Sequence Number: 19590745
• Product Code: GCJ
• UDI-Device Identifier: 10705036012511
• UDI-Public: 10705036012511
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 05/31/2025
• Device Model Number: EPS07
• Device Catalogue Number: EPS07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.