MAUDE Adverse Event Report: TELEFLEX MEDICAL MINIGRIP ALLIGATOR GRASPER; ENDOSCOPIC TISSUE APPROXIMATIO

Model Number	IPN914229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
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
Shaft of pgac300 broke towards the distal tip of the product when armed and inserting into the abdomen.
Event or Problem Description
Shaft of pgac300 broke towards the distal tip of the product when armed and inserting into the abdomen.
Additional Manufacturer Narrative
(b)(4).The dhr was reviewed.All operations and documentation were completed and acceptable.The device was manufactured on september 16, 2020.Root cause: the cause of the damaged device is undetermined.It is likely that the device was damaged due to excessive force applied while inserting or guiding the needle through the abdomen.An "instruction for use" (ifu) is placed in each min igrip device sales unit.This is a requirement listed on the minigrip device sales unit print, part number tfx-001091 rev 2.Placement of ifu in each sale unit is mandatory per work instruction, wl-cr-9.4 packaging sterilized product.Corrective actions implemented: root cause is unknown , and no corrective actions are necessary at this time.

• Brand Name: MINIGRIP ALLIGATOR GRASPER
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12569122
• Report Number: 3011137372-2021-00265
• Device Sequence Number: 17157165
• Product Code: OCW
• UDI-Device Identifier: 14026704640086
• UDI-Public: 14026704640086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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 Expiration Date: 09/16/2025
• Device Model Number: IPN914229
• Device Catalogue Number: PGAC300
• Device Lot Number: GML-00340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1