MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unk.Investigation summary: the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field.This blade tip portion may have broken off of the device during transport to our analysis site.During functional testing on gen11, an alert screen was displayed.A probable cause for the device to stop activating and the gen11 to display an alert screen is blade damage.The device was analyzed, and it was determined that it was connected in more than one generator.The device is intended and labeled for single patient use.If the device is connected to multiple generators an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.The device was disassembled to inspect the internal components and no anomalies were found.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This device is packaged and sterilized for single use only.Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result include, ¿tighten assembly,¿ ¿blade error detected¿ or "relaxed pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.

Event Description

It was reported that a ¿tighten assembly¿ alert screen displayed by the generator during procedure.Changed to another one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: HARMONIC LAP 5MM SHEAR 36CM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9603886
• MDR Text Key: 198887367
• Report Number: 3005075853-2020-00453
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: 10705036014447
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: HAR36
• Device Lot Number: R93Y46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1