MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HP054

Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p9270k.Investigation summary the handpiece was received with the nose cone cracked and the mount was noted to be loose.No functional testing could be performed due to the nose cone was extremely cracked and no instrument could be attached to the handpiece.The instrument was disassembled to inspect internal components.The moisture indicator was positive.The transducer assembly was not held in place due to the cracked nose cone, so torquing on the disposable resulted in twisting only the handpiece transducer assembly until the internal wires got disconnected.Due to the cracked nose cone, moisture entered the hand piece mid housing.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nosecone.It is possible that the ingress of moisture affected handpiece functionality.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that prior to a gastric sleeve procedure the scrub tech was unable to tighten the instrument to the hand piece.There were no clicks, it just spun.They were also unable to remove the instrument from the hand piece.There was no patient involvement.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• 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: 7179230
• MDR Text Key: 96941279
• Report Number: 3005075853-2018-07201
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: 20705036002144
• Combination Product (y/n): N
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/18/2017

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 Catalogue Number: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1