MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR INSERTER-EXTRACTOR HANDLE; KWT, HSD

Model Number 9013.02.303

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

Check of dhr of the handle involved (lot # 2015aa499) did not show any pre-existing anomaly.(b)(4).The instrument involved is not available for investigation.We received information that, once returned to lima (b)(4), the instrument was lubricated and after the lubrication it was fully functional.So the intra-op seizure was caused by a missed lubrication of the handle before use.The ifu related to cleaning, sterilization and maintenance of these instruments already advise that a lubrication is needed on hinged, rotating, or articulating instruments before using them.No corrective actions for this case.Lima corporate will keep monitored the market.

Event Description

During surgery, the lever of the introducer handle (model # 9013.02.303) seized.This caused difficulties when removing the pushrod tip for humeral body medium from the handle.Surgery prolonged of 10 minutes because of this.No adverse effect for patient.The event occurred in (b)(6).

• Brand Name: SMR INSERTER-EXTRACTOR HANDLE
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; IT
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 5331525
• MDR Text Key: 35063963
• Report Number: 3008021110-2015-00057
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.303
• Device Lot Number: 15AA499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization