MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE SHEARS 5MM X 36CM; HARMONIC SCALPEL

Model Number HAR36

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2017

Event Type  malfunction  

Event Description

With initial use of the stryker sustainability solutions, harmonic ace shears it was observed that metal shards had broken off the tips of the harmonic scalpel into the patient.Patient copiously irrigated with lr solution and suctioned utilizing a nezhat irrigator.Metal shards not seen during this process.Diagnosis or reason for use: laparoscopic bilateral oophorectomy.Is the product compounded: no.Is the product over the counter: no.Event abated after use stopped or dose reduced: no.

• Brand Name: HARMONIC ACE SHEARS 5MM X 36CM
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 6499819
• MDR Text Key: 73222546
• Report Number: MW5069138
• Device Sequence Number: 1
• Product Code: NLQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2017
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 5533739
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR