MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARHD36

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #t94t4z.Investigation summary: the device was returned with the jaws misaligned and the clamp arm damaged.Upon further analysis of the tissue pad, an off-center burn in was observed.The device was tested on a gen11.The device did activate.No "difficulty to open or close" issues could be identified during testing, however, due to the reported event, the complaint can be confirmed.The device was disassembled to inspect the internal components and no anomalies were found.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Our manufacturing process has been identified to be the possible cause of the misaligned jaw issue.

Event Description

It was reported that during a laparoscopic sigmoidectomy, the surgeon felt that the jaws were misaligned from the beginning.The blade tip was not broken off and no pieces fell into the patient.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 HD 1000I SHEARS 36CM SHAFT
• 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: 10067177
• MDR Text Key: 191690623
• Report Number: 3005075853-2020-02655
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARHD36
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Date Manufacturer Received: 04/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1