MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 23CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR23

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device was returned with the distal tip of the blade broken off and it was returned with the device.The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field.The device was connected to a test hand piece and a gen11.The device was analyzed, and it was determined that it was possibly used in more than one procedure, based on generator data.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¿.No unexpected ready to pre run issues were identified as reported by the customer.The device was disassembled to inspect the internal components.Corrosion was found at the hand activation domes.Due to the moisture discovered on the instrument, which is evidence of possible reuse, we are unable to determine how this condition impacted the performance of the device and, therefore, cannot conclude root cause.Our manufacturing, sterilization, packaging, and shipment processes do not introduce corrosion / moisture to the device.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 are such as ¿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.Due to the multiple generator usage, which is evidence of possible reuse, we are unable to determine how this condition impacted the performance of the device and, therefore, cannot conclude root cause.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.

Event Description

It was reported that the scalpel passed first pre-run test.After working several minutes, the scalpel was required to pre-run by the system again.The scalpel could not work uninterruptedly.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 23CM
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8971458
• MDR Text Key: 156912520
• Report Number: 3005075853-2019-21776
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014430
• UDI-Public: 10705036014430
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: HAR23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1