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

Model Number HAR36

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2015

Event Type  malfunction  

Event Description

Stryker sustainability solutions, harmonic ace shears.Portion of device loose and working ends did not meet.Reason for use: diagnostic laparoscopy, lysis of adhesions.

• Brand Name: HARMONIC ACE SHEARS
• Type of Device: HARMONIC SCALPEL, 5 MM X 36 CM
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; lakeland FL 33815
• MDR Report Key: 5011196
• MDR Text Key: 23389962
• Report Number: MW5055467
• 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
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2016
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 3759497
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR