MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY-HYDRAGRIP SURGICAL CLAMPS; CLAMP, VASCULAR

Model Number	SOFT33
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
As reported, during use with these clamps soft33, the black inserts fall out of the vascular clamp with some regularity, the inserts fall out inside the patients but they were able to manually remove them, without a need of an additional intervention.The total units with this issue were unknown.There was no allegation of patient injury.The devices were available for evaluation.
Additional Manufacturer Narrative
The device involved in this complaint was received for evaluation.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Additionally, it could be verified that there are current inspection controls in place, to prevent this type of malfunction in our manufacturing process.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Edwards will continue to review and monitor all events.

• Brand Name: FOGARTY-HYDRAGRIP SURGICAL CLAMPS
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20382768
• Report Number: 2015691-2024-07612
• Device Sequence Number: 12772048
• Product Code: DXC
• UDI-Device Identifier: 00690103045727
• UDI-Public: (01)00690103045727(17)261203(11)231204(10)65484897
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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 Model Number: SOFT33
• Device Lot Number: 65484897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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