MAUDE Adverse Event Report: TELEFLEX MEDICAL MEDIUM HEMOLOK TAKEAPART APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN915188
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
No patient harmed, or reported in this incident.Cssd manager reported that surgeon communicated the applier is not working properly and believes there is an issue with the handle.Additional information: the clip would load normally.The issue presented once the clip was placed, the jaws would not release.
Additional Manufacturer Narrative
Qn# (b)(4).Original manufacturing lot is 21941301: upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.During visual and functional examination, we found the following: pull rod bent/deformed.Due to deformation of the pull rod the applier does not work properly.Due the deformed pull rod applier does not work properly.Why the pull rod is bent is unknown to us.The point of deformation suggests an event in the disassembled state.No further measures will be initiated.
Event or Problem Description
No patient harmed, or reported in this incident.Cssd manager reported that surgeon communicated the applier is not working properly and believes there is an issue with the handle.Additional information: the clip would load normally.The issue presented once the clip was placed, the jaws would not release.

• Brand Name: MEDIUM HEMOLOK TAKEAPART APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11342683
• Report Number: 3011137372-2021-00047
• Device Sequence Number: 14701700
• Product Code: GDO
• UDI-Device Identifier: 24026704709902
• UDI-Public: 24026704709902
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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: IPN915188
• Device Catalogue Number: 544945T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1