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

Model Number	IPN914223
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that when the tissue was grasped and the gripper was locked, the instrument-shaft was moved over the gripper and the grasped tissue.During this process, the sharp shaft punched two holes in the tissue, which protruded from the side of the gripper.The user has been instructed about the handling before the surgery.
Additional Manufacturer Narrative
(b)(4), the device history record for the subject device was reviewed and there was no indication of a problem that could be attributed to the reported event.Upon review of the complaint description, it was reported that "when the tissue was grasped and the gripper was locked, the instrument-shaft was moved over the gripper and the grasped tissue.During this process, the sharp shaft punched two holes in the tissue, which protruded from the side of the gripper.The user has been instructed about the handling before the surgery".We were not able to confirm the reported event.The device is not available for analysis.The complaint description suggests that the user did not follow instructions for use.Based upon the complaint history and our internal acceptance records, we cannot substantiate the reported event.
Event or Problem Description
It was reported that when the tissue was grasped and the gripper was locked, the instrument-shaft was moved over the gripper and the grasped tissue.During this process, the sharp shaft punched two holes in the tissue, which protruded from the side of the gripper.The user has been instructed about the handling before the surgery.
Additional Manufacturer Narrative
(b)(4).It was reported that the patient's gender and weight are unknown.The underlying medical condition was functional impairment of the kidney.The ureter was injured by the minilap gripper but the ureter should have been and was removed during the surgery as planned together with the kidney.The ureter is the part that had holes punched from the grasper gripper.Bleeding occurred reportedly from the harmed tissue whereupon an electrosurgical sclerotherapy was performed further in the procedure.The procedure was challenging according to the instructions for use; the user is experienced.The ureter was removed according to plan.No harm was done to the patient from the holes in the tissue and no medical intervention was necessary after the holes in the tissue were formed.The patient's condition is reported as fine.

• Brand Name: CLUTCH 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: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 15484580
• Report Number: 3011137372-2022-00191
• Device Sequence Number: 12065298
• Product Code: OCW
• UDI-Device Identifier: 14026704640079
• UDI-Public: 14026704640079
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: IPN914223
• Device Catalogue Number: CLC250
• Device Lot Number: ML000622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 09/29/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 09/30/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown