MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM COUPLER FORCEPS

Model Number	519306001010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tips of a coupler forceps are damaged/bent.This was observed prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6, and h11: h4: the lot was manufactured between july 15, 2024 ¿ july 17, 2024.H11: the device was received for evaluation.A visual inspection was performed, and misalignment and bent tips when closed together was observed.The returned coupler forceps tips were brought together to mimic the motion that would be utilized in a surgical process.This visual investigation showed that the returned forceps could not simulate the intended use.The forceps did not function as intended as the two halves of the forceps did not perfectly match.The reported condition was verified.The cause of the condition could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.The device malfunction was assessed as unlikely to cause or contribute to serious injury as it is likely to be detected during inspection and prior to use.Furthermore it is likely that the device is rendered unusable.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM COUPLER FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL - MCA; 2575 university ave w.; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23578158
• Report Number: 1416980-2025-05695
• Device Sequence Number: 9222745
• Product Code: HTD
• UDI-Device Identifier: 00844735002850
• UDI-Public: (01)00844735002850(10)SP25E29-2286709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: Other
• Device Model Number: 519306001010
• Device Catalogue Number: 519306001010
• Device Lot Number: SP25E29-2286709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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