MAUDE Adverse Event Report: TELEFLEX MEDICAL JACKSON ANG 6MM CUP FCPS 28CM; FORCEPS, GENERAL & PLASTIC SUR

Model Number	IPN007777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the angled cup biter was being used by the doctor to obtain a lymph node biopsy.Handle of biter came apart while in use.The instrument was immediately removed from the field.X-ray was obtained prior to surgical incision closure.Absence of retained object was verified by the doctor and radiologist.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted.These instruments feature a removeable handle which must be properly reassembled.Removal of the handle is not required for cleaning and should only be performed by qualified technicians.Incorrect assembly of the handle results in failure to function and unexpected disassembly when the retaining tab is not correctly seated.Proper assembly can be easily confirmed by looking at the handle/tab and slot interface.The device has been validated for sterilization without disassembly.If the sample is received it can be reassembled and return to the customer.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the angled cup biter was being used by the doctor to obtain a lymph node biopsy.Handle of biter came apart while in use.The instrument was immediately removed from the field.X-ray was obtained prior to surgical incision closure.Absence of retained object was verified by the doctor and radiologist.

• Brand Name: JACKSON ANG 6MM CUP FCPS 28CM
• Common Device Name: FORCEPS, GENERAL & PLASTIC SUR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15550565
• Report Number: 3011137372-2022-00196
• Device Sequence Number: 17661553
• Product Code: JEK
• UDI-Device Identifier: 24026704530643
• UDI-Public: 24026704530643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K990561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: IPN007777
• Device Catalogue Number: 505106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown