MAUDE Adverse Event Report: SURGICAL SPECIALTIES PUERTO RICO INC. LASEREDGE; SLIT KNIFE FULL HDL 2.75 MG ANG

Model Number E7559A

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/16/2015

Event Type  malfunction  

Event Description

¿scrap metal into patient eye, visible with microscope.(b)(6), 2015: no patient impact or any complication was reported.¿ (b)(4).

Manufacturer Narrative

The actual product involved with the incident reported will not be returned.No unused product from the same lot reported will be returned for evaluation.No inventory available for the finished good lot number reported or finished good product manufactured with the same blade component lot available.Method: the actual device will not be returned.No unused product from the same lot reported will be returned for evaluation.Results/conclusion: the actual device will not be returned.Relevant portions of the device history record were reviewed for corresponding issues identified during the manufacturing processes or at the final inspection.Finished good product was received into inventory without quality issues.No inventory available for the finished good lot reported nor product manufactured with the same blade component lot.The blade component supplier was contacted and met requirements throughout the manufacturing and sheathing processes prior to release as well as inspections at our facility.

• Brand Name: LASEREDGE
• Type of Device: SLIT KNIFE FULL HDL 2.75 MG ANG
• Manufacturer (Section D): SURGICAL SPECIALTIES PUERTO RICO INC.; aguadilla PR
• Manufacturer Contact: marcia caro, sr. qa manager ; road 459 km 0.6; montana industrial park; aguadilla, PR 00603 ; 7876581800
• MDR Report Key: 4463039
• MDR Text Key: 5399620
• Report Number: 3008845715-2015-00004
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: E7559A
• Device Catalogue Number: E7559A
• Device Lot Number: MCDJ000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE MADE AVAILABLE
• Patient Outcome(s): Required Intervention