MAUDE Adverse Event Report: SKLAR CORPORATION SKLAR®; SCISSORS, GENERAL, SURGICAL

Model Number	96-2504C
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rn reported a new sterile package of iris scissors was opened and scissors immediately broke causing the nurse to sustain a puncture.There was no serious harm to the nurse or the patient.An employee injury form was completed and the scissors are being returned to the manufacturer by the nursing unit.Manufacturer response for scissors, general, surgical, sklar® (per site reporter).The nursing unit contacted sklar corp directly.A complaint file was opened and the device will be returned for failure analysis.The status is currently unknown, but will be shared when/if it becomes available.

• Brand Name: SKLAR®
• Common Device Name: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): SKLAR CORPORATION; 889 south matlack street; west chester PA 19382
• MDR Report Key: 8314397
• Report Number: 8314397
• Device Sequence Number: 1619564
• Product Code: LRW
• UDI-Device Identifier: 50649111170575
• UDI-Public: (01)50649111170575
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2019
• Report Date (Section F): 01/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: 96-2504C
• Device Lot Number: 01198405
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/30/2019