MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ZIPCLIP; CLIP, IMPLANTABLE

Model Number	GEM1500
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of an automatic microclip applier (zipclip), a clip rotation issue occurred.The microclip was applied to the vessel with no issues.When the device jaws opened, the next clip loaded sideways in the jaw.The surgeon observed this and passed the device to surgical tech.A new zipclip device was passed to the surgeon and the case continued.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6 an h11.Corrected information: g3.G3: initial mdr submitted with incorrect g3 date.The correct g3 date is 08/25/2025 (08/26/2025 was incorrectly submitted).H11:the device was discarded and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4 lot and udi #, h6 (add code).Correction to previous h11 in follow up #1: g3 date referenced was incorrect (replace back with 08/26/2025).H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: h11 - this device malfunction is not likely to cause or contribute to a serious injury.When a clip spins and is sideways in the jaw the surgeon will detect it on the scope and is unable to place it on the vessel making it unusable.The user may opt to use a new unit or else resort to alternate methods or surgical techniques.Hence if the issue recurs it is unlikely to cause or contribute to serious injury.

• Brand Name: ZIPCLIP
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): 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: 23151497
• Report Number: 1416980-2025-04836
• Device Sequence Number: 5290588
• Product Code: FZP
• UDI-Device Identifier: 00844735006384
• UDI-Public: (01)00844735006384(10)25084ZC-PQ1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2026

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: Health Professional
• Device Model Number: GEM1500
• Device Catalogue Number: MS-5295-00001-061
• Device Lot Number: 25084ZC-PQ1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 11/05/2025; 04/02/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/23/2025; 11/21/2025; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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