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	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jaw broke during use.There was no reported injury.
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
Qn#(b)(4).Additional information: the rupture occurred inside the abdomen in a completely unexpected way, while reopening the forceps that supported the gallbladder, the branch broke.It was noticed by extracting the instrument.The fragment was found and was extracted whole.The returned device was received by the quality department.The device was in a plastic bag with outer "disinfection tag".Part was found to have the jaws bent backwards towards the handle of the device, with one broken off.All other parts were intact.No manufacturing flaws were observed.The dhr was reviewed by qa.All operations and documentation were completed and acceptable.The device was manufactured on september 16, 2020.The root cause of the damaged device is undetermined.It is likely the device was damaged due to excessive force or incorrectly arming the device before inserting or guiding through the body.It is possible that the user did not fully arm the device and attempted to insert the device with the jaws exposed (not safely behind the needle point).The damage is consistent with a device that is not fully armed.An "instruction for use" {ifu) is placed in each minigrip device sales unit per the teleflex specifications.This is a requirement listed on the minigrip device sales unit.Placement of the ifu in each sales unit is mandatory.Root cause is unknown and no corrective actions are necessary at this time.
Event or Problem Description
It was reported that the jaw broke during use.There was no reported injury.

• Brand Name: MINIGRIP ALLIGATOR GRASPER
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15920025
• Report Number: 3011137372-2022-00237
• Device Sequence Number: 14539959
• Product Code: OCW
• UDI-Device Identifier: 24026704640083
• UDI-Public: 14026704640086
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/20/2023
• 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 Age: 49 YR
• Patient Sex: Unknown