MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 1100 SHEARS, 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR1136

Device Problems Failure to Read Input Signal (1581); Difficult or Delayed Activation (2577)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure the device stopped working.The generator displayed "remove instrument and clean" message.After pressing "next" the generator displayed "replace instrument." the surgeon switched over to harh36 to complete the case and no further issues were noted.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 3/22/2024.B3: event year only reported: 2024.D4 batch #: x7043g.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.  visual analysis of the returned sample determined that 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.In addition, the device was returned with the cable cut off.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 of the device stop activating and display an alert screen is blade damage.The device was disassembled to verify the internal components and no anomalies were found.  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.  once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as "remove instrument from patient" or ¿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.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.  a manufacturing record evaluation was performed for the finished device lot/batch x7043g, and no non-conformances were identified.

• Brand Name: HARMONIC 1100 SHEARS, 36CM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18961165
• MDR Text Key: 338380817
• Report Number: 3005075853-2024-02331
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036026167
• UDI-Public: 10705036026167
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR1136
• Device Lot Number: X7043G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.