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

Catalog Number	CLC250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the jaws with the teeth fall out, one piece falls into the patient and one piece is left on the patient's abdominal wall".Additional information received states that all pieces were successfully retrieved from the patient".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "the device was returned, and the reported event was confirmed.A review of the dhr did not indicate any reasons to suspect a manufacturing defect.A review of the complaint history for the previous 48 months did not indicate any similar confirmed events.The cause of the event cannot be determined.The cause is of the reported event could not be confirmed.No corrective action required." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the jaws with the teeth fall out, one piece falls into the patient and one piece is left on the patient's abdominal wall".Additional information received states that all pieces were successfully retrieved from the patient".No patient harm or injury.The patient status 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20066167
• Report Number: 3011137372-2024-00129
• Device Sequence Number: 7839877
• Product Code: OCW
• UDI-Device Identifier: 14026704640079
• UDI-Public: (01)14026704640079(11)240109(17)260109(10)ML-000774(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 01/09/2026
• Device Catalogue Number: CLC250
• Device Lot Number: ML-000774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown