MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HP054CN

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: v95841.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.

Event Description

It was reported that prior to an unknown procedure the staff found the wrong dom on the english label.It wasn't used on patient.No additional information can be provided.

Manufacturer Narrative

(b)(4).Date sent: 10/28/2021.This is an analysis for an image submitted to ethicon endo surgery for evaluation.Image 1: the image provided by the customer is that where the manufacturing date from an hp054 package label can be observed.The image provided by the customer is that of what appears to be an hp054 package.A closer look at the label shows the manufacturing date incorrect.No conclusion could be reached as to how this issue occurred through photo analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspections were conducted on the returned device.Visual analysis of the returned sample revealed that one hp054 device was returned inside its package unopened; upon visual inspection, it was noted that the packaging identification came with its unusual manufacturing date.As part of our quality process, the manufacturing records of this lot number were 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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12592623
• MDR Text Key: 275405761
• Report Number: 3005075853-2021-06035
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HP054CN
• Device Lot Number: V95841137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/07/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR