MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number HAR36

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use and an indention in the teflon pad was identified.The blade showed signs of melted debris which appeared to be a drape.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore, the most likely root causes may be attributed to: tissue accumulation between the blade and shaft.Prolonged activation (in general or against solid surfaces), repeated use of instrument beyond intended use.User selects improper min generator settings.User activates on max instead of min.Ancillary equipment error (e.G.Handpiece and/or generator).The instructions for use (ifu) state: ¿a thorough understanding of the principals and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device¿¿ ¿the entire exposed blade tip and any exposed blade shaft are active and will cut/coagulate tissue when the instrument is activated.Be careful to avoid inadvertent contact between all exposed blade surfaces and surrounding tissue when using the instrument.¿ ¿during and following activation in tissue, the instrument blade, clamp arm, and distal 7 cm of the shaft may be hot, avoid unintended contact with tissue, drapes, surgical gowns, at all times." the reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the shaft of the harmonic scalpel burned the colon while the device was being used to dissect adjacent tissue.The patient was treated for the burn via laparoscopic suture repair of colotomy.No extended procedure time was reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5709137
• MDR Text Key: 46896749
• Report Number: 0001056128-2016-00076
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2017
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 4428908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1