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 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: v94l86.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.

Event Description

It was reported that the distributor found an incomplete manufacture date on the english label.It showed "2021-04-".This device was in distributor and not used on patient.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Date sent: 9/15/2021.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was returned with returned outside its original packaging and the packaging was not returned.In addition, it was returned with no apparent damage.Due to the device packaging not being returned, we are unable to investigate further on the reported packaging identification.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.This is a analysis for an image submitted to ethicon endo surgery for evaluation.Image: the image provided by the customer is that where the label from a hp054 package with a missing manufacturing year could be observed.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 quality system.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: 12318823
• MDR Text Key: 266411569
• Report Number: 3005075853-2021-04706
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: V94L86115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR; GENERATOR