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

Model Number EPS06

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that the customer ordered probes with spatula, but the products that arrived were probe hooks.The packaging says spatula, but the product inside is hook.Customer did not discover this until they opened the package prior to the case.Customer states that they used the device without issue and there was no apparent consequence to patient.However, given the mismatched packaging and potential safety concerns, they would like replacement products (spatula).No patient harm was reported.

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: only event year known: 2022.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 3/29/2022.D4 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 (e) was returned inside its package unopened; upon visual inspection, the device was received with incorrect device packaged/labeling.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Type of Device: 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13731697
• MDR Text Key: 287028379
• Report Number: 3005075853-2022-01518
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012504
• UDI-Public: 10705036012504
• Combination Product (y/n): N
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPS06
• Device Catalogue Number: EPS06
• Device Lot Number: U94Y4V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1