MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON; HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM

Catalog Number HAR36MRH

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a hysterectomy, the tip of the reprocessed harmonic ace®+ shears w/o adaptive tissue technology 36cm broke off and fell into surgical site.Per report, the device tip was successfully retrieved from the patient through an unidentified method.There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident.Due to the reported event and required medical intervention to retrieve the device tip from the surgical site, this medwatch is being filed.The device is not available to be returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the reprocessed ethicon harmonic ace®+ shears w/o adaptive tissue technology 36cm broke off and fell into the surgical site.

• Brand Name: ETHICON
• Type of Device: HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8448278
• MDR Text Key: 139994161
• Report Number: 3032391-2019-00003
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR36MRH
• Device Lot Number: 393871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention