MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number	LF1637
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The facility sent the device to sterilmed for reprocessing.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot/serial number was not reported.The reported event could be attributed to damage to the identification label on the plug due to handling conditions.The instructions for use (ifu) state: - the lf1637 instrument is intended for use only with the covidien forcetriad energy platform.Use of this instrument with other covidien generators or with generators produced by other manufacturers may not result in the desired tissue effect, may result in injury to the patient, or surgical team, or may cause damage to the instrument.- these instruments are only intended for use by individuals with adequate training and familiarity with the specific procedure being undertaken.Use of this equipment without such training may result in serious unintended patient injury.For further information about techniques, complications and hazards, consult the medical literature.- before beginning the procedure, verify overall compatibility of all instruments and accessories.- insert the connector into the receptacle on the generator.Follow the instructions in the generator user¿s guide to complete the setup procedure.- inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker if it is not in acceptable condition for the procedure.- examine all ligasure system and instrument connections before using.Improper connection may result in arcing, sparks, accessory malfunction, or unintended surgical effects.- inspect the instrument and cords for breaks, cracks, nicks, or other damage before use.Failure to observe this caution may result in injury or electrical shock to the patient or surgical team or cause damage to the instrument.If damaged, do not use.The reported event will continue to be monitored through post-market surveillance.(b)(4).
Event or Problem Description
It was reported the patient was scheduled for a lap nissen.The patient was anesthetized and intubated.An incision was made and the trocar was placed.When hooking up the ligasure, the triad unit signaled an error message stating the instrument was not recognized.The procedure was stopped and troubleshooting was performed on the equipment.Covidien was called to determine the cause of the error message and to see if the problem could be fixed.They stated the software must be updated by a covidien service person.The decision was made to cancel the case and reschedule the patient.A subsequent procedure was scheduled and completed.The patient has made a full recovery.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6464990
• Report Number: 0001056128-2017-00056
• Device Sequence Number: 563534
• Product Code: NUJ
• UDI-Device Identifier: 00885825017620
• UDI-Public: (01)00885825017620
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K133578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LF1637
• Device Catalogue Number: LF1637RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 39 YR