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

Model Number IPN914229

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Shaft of pgac300 broke towards the distal tip of the product when armed and inserting into the abdomen.

Event Description

Shaft of pgac300 broke towards the distal tip of the product when armed and inserting into the abdomen.

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
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12569122
• MDR Text Key: 274521993
• Report Number: 3011137372-2021-00265
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 14026704640086
• UDI-Public: 14026704640086
• Combination Product (y/n): N
• PMA/PMN Number: K172775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1