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

Model Number HAR36

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - shipping damage, handling damage subsequent to distribution from stryker sustainability solutions - applying pressure between instrument blade and tissue pad without having tissue between them.- prolonged activation (in general or against solid surfaces).- repeated use of instrument beyond intended use.The instructions for use (ifu) state: - care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message.- for optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.Note: do not touch the instrument to metal while activated.Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.- if tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged.A supplemental mdr will be submitted once the device evaluation is completed.The reported event will continue to be monitored through post-market surveillance.(b)(4).

Event Description

It was reported the teflon pad came off the jaws of the harmonic scalpel inside the patient.The pad was retrieved using forceps and the device was replaced.There was no patient injury, medical intervention, and extended procedure time reported was not more than a few minutes.These are commonly used devices that are readily available.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Visual inspection of the device revealed the teflon pad was not attached to the jaw.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the teflon pad came off the jaws of the harmonic scalpel inside the patient.The pad was retrieved using forceps and the device was replaced.There was no patient injury, medical intervention, and extended procedure time reported was not more than a few minutes.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: 6350238
• MDR Text Key: 68378842
• Report Number: 0001056128-2017-00038
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)170809(10)4809071
• 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,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2017
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 4809071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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