MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM COUPLER FORCEPS

Model Number	GEM4183C
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 two (2) coupler forceps had bent tips.This occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction: d4: unique identifier (udi)#, h5.Additional information: d9, h3, h6 (update codes), h11.H11: two (2) actual samples and photographs of the samples were provided for evaluation.Visual inspection of the photographs identified a bent tip and a sample that appeared to have been incorrectly packaged.Visual inspection of the actual samples did not identify visible discoloration or damage to the forceps, which is consistent with the report of the issue observed prior to use.Further inspection observed the tips of the forceps were misaligned.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause could not be determined.However, this event is likely to be detected prior to use and renders the device unusable.The issue is unlikely to cause or contribute to serious injury.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 ; 2242705355
• MDR Report Key: 24416710
• Report Number: 1416980-2026-00671
• Device Sequence Number: 16096441
• Product Code: HTD
• UDI-Device Identifier: 00844735002850
• UDI-Public: (01)00844735002850(10)SP25I18-2342783
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: GEM4183C
• Device Catalogue Number: 519306001010
• Device Lot Number: SP25I18-2342783
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown