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

Catalog Number HARH36RH

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that the tip broke off in the patient.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample is not available to be 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

It was reported by the facility that the tip broke off in the patient.No additional details are available.

Manufacturer Narrative

Update: d4, d9, g6, h1-3, h6 device from an alternate lot was returned for evaluation, however, a definitive root cause cannot be determined at this time.

• Brand Name: HARMONIC ACE+7 SHEARS 5MM X 36CM
• 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: 15136720
• MDR Text Key: 296950702
• Report Number: 3032391-2022-00008
• 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,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARH36RH
• Device Lot Number: 463049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/30/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other