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

Catalog Number HP054

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n91t72.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 acoustic isolator was torn.The transducer assembly was not held in place due to the cracked nose cone, so torqueing on the disposable resulted in twisting only the handpiece transducer assembly until the internal wires got disconnected.The nose cone cracked cloud caused the reported assembly or disassembly issues.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 during an unknown procedure the hand piece could not be tight on the scissor.Another device was used to complete the case.No patient consequences.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6828861
• MDR Text Key: 83981616
• Report Number: 3005075853-2017-04240
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002906
• 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: 06/28/2017

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: 08/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1