MAUDE Adverse Event Report: MEDLINE RENEWAL; HARMONIC ACE+7 SHEARS 5MM X 36CM

Catalog Number HARH36RH

Device Problems Melted (1385); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility during a procedure 'a white piece came off the harmonic scalpel and melted inside the patient'.Per the facility the event happened during the 'middle to end' of the procedure, and the piece was unable to be retrieved.According to the facility, they reported that the procedure was completed and there was no reported serious injury or medical intervention noted.The device is available but has not been returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility during a procedure 'a white piece came off the harmonic scalpel and melted inside the patient'.

• Type of Device: HARMONIC ACE+7 SHEARS 5MM X 36CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15070242
• MDR Text Key: 296288749
• Report Number: 3032391-2022-00006
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARH36RH
• Device Lot Number: 469971
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 93 KG