MAUDE Adverse Event Report: TELEFLEX MEDICAL NO SCALPEL HEMOSTAT SHARP

Model Number	IPN004677
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device tip was too sharp and cut an employee when taking it out of the bag.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).Sample of 244000 lot t2 was received for evaluation.No visual concerns were noted with the sample.A dimensional or functional inspection was not required as part of this investigation.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 244000.The device is fabricated according to the design specification.The "no scalpel" vasectomy forceps features sharp tips by design.The "no scalpel" method utilizes the sharp tips to puncture the scrotal tissue in lieu of a scalpel and must be sharp to perform the procedure correctly.
Event or Problem Description
It was reported that the device tip was too sharp and cut an employee when taking it out of the bag.

• Brand Name: NO SCALPEL HEMOSTAT SHARP
• Common Device Name: HEMOSTAT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15992101
• Report Number: 3011137372-2022-00243
• Device Sequence Number: 12561369
• Product Code: HRQ
• UDI-Device Identifier: 24026704515305
• UDI-Public: 24026704515305
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: IPN004677
• Device Catalogue Number: 244000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Female