MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB; INSORB SUBCUTICULAR SKIN STAPLER

Model Number	2030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and the insorb stapler was used.Several hours post-op, the patient experienced wound dehiscence.Device was discarded.Multiple attempts were made, but no additional information is available.1216677-2025-00008 2030 insorb 2025-01-0000172.
Additional Manufacturer Narrative
Device has been discarded.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint products were manufactured at csi on 9/27/2024.Manufacturing record review: dhr was reviewed, and no nonconformities related to the complaint condition were noted.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions, however, in those cases no product was returned for investigation, so the complaints were not confirmed.Product receipt: the complaint product was not available for return.However, (b)(4).Closed boxes and (b)(4).Unused individual staplers from the same lot number that were under quarantine was received on 02/12/2025.Visual evaluation: packaging: all returned products were verified to have no breach to the sealed packaging.Seal condition: the returned product was verified to display a minimum 1/8 inch seal.Desiccant packs: the desiccant packs did not indicate prolonged exposure to moisture.Storage conditions: six outer boxes with temperature indicators were returned and all the temperature indicators were found ok and not triggered.Visual examination of the complaint products revealed no physical damage.Functional evaluation: all products were functionally evaluated, all were completely shot and emptied.In addition, an aql was made where all the staples were measured and found to pass.Any relevent customer or clinical information : according to the follow up emails: all supplies are stored in a climate-controlled environment.Root cause: no definitive root cause for this issue could be reliably determined at this time.The returned product was tested to specifications.Coopersurgical will continue to monitor this complaint condition for trends.Complaint is not confirmed as the product tested to specifications.
Event or Problem Description
No additional information.

• Brand Name: INSORB
• Common Device Name: INSORB SUBCUTICULAR SKIN STAPLER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 21323683
• Report Number: 1216677-2025-00008
• Device Sequence Number: 15567597
• Product Code: GDW
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104(10)619048963
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 619048963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown