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	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "a piece broke off in patient during procedure.Procedure lasted 1 hour longer due to looking for piece that broke off".Additional information received states that "a piece of one of the arms of the alligator forceps broke off during the case and so we had to get the fluoroscopic guidance per radiology to help find the missing piece and then remove it from the patient's abdominal wall." all pieces were successfully removed from the patient.Another device was not used to complete the procedure.No patient harm or injury.The patient status is reported as "good".
Event or Problem Description
It was reported that "a piece broke off in patient during procedure.Procedure lasted 1 hour longer due to looking for piece that broke off".Additional information received states that "a piece of one of the arms of the alligator forceps broke off during the case and so we had to get the fluoroscopic guidance per radiology to help find the missing piece and then remove it from the patient's abdominal wall." all pieces were successfully removed from the patient.Another device was not used to complete the procedure.No patient harm or injury.The patient status is reported as "good".
Additional Manufacturer Narrative
(b)(4).The reported complaint of " piece broke off in patient during procedure" was confirmed upon the visual inspection of the returned pgac300 minigrip alligator grasper.The returned device was in a plastic bag with outer "disinfection tag".Part was found to have the jaws bent, with one broken off.All other parts were intact.No manufacturing flaws were observed.A device history record review was performed, and no relevant findings were identified.The root cause of the damaged device was undetermined.A possible root cause could be caused during shipping and handling due to excessive force or incorrectly arming the device before inserting or guiding through the body.It was also possible that the user did not fully arm the device and attempted to insert the device with the jaws exposed.No further actions required at the time of the report.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17292009
• Report Number: 3011137372-2023-00173
• Device Sequence Number: 17523692
• Product Code: OCW
• UDI-Device Identifier: 14026704640086
• UDI-Public: 14026704640086
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K172775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: IPN914229
• Device Catalogue Number: PGAC300
• Device Lot Number: GML-00402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/30/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown