MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HDH05

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #r94v8h.Investigation summary: the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched 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 manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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 damage severity and can result in not passing the pre-run test followed by an alert screen, such as ¿tighten assembly,¿ ¿blade error detected¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage can result in a broken blade.

Event Description

It was reported that during a laparoscopic oophorectomy, the device would not activate and coagulate during use.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10051878
• MDR Text Key: 192193439
• Report Number: 3005075853-2020-02600
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002109
• UDI-Public: 10705036002109
• Combination Product (y/n): N
• PMA/PMN Number: K990362
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: HDH05
• Device Catalogue Number: HDH05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1