MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB; SKIN STAPLER/STAPLE, BIOABSORBABLE

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	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an unknown surgery and experienced a partial wound dehiscence within 24 hours post closure.Patient was returned to surgery for closure.Attempts were made, but no additional information was provided.(b)(4).
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h11 distribution history the complaint product was manufactured by csi.Manufacturing record review a review of the device history record could not be performed because the lot/serial number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history is not applicable for this product.Historical complaint review a review of the 2-year complaint history showed similar reported complaint conditions for wound separation.However, no evidence of manufacturing issues was found in those cases.Product receipt the complaint product was not received at csi.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause based on the information available, no definitive root cause could be determined.The reported wound dehiscence occurred in a timeframe in which multiple non device related factors may contribute.There is insufficient information to confirm a causal relationship with the device, procedure, or patient condition.Early post operative wound dehiscence may be associated with multiple factors such as patient related conditions, wound tension, infection, or mechanical stress; however, no evidence is available to attribute causation in this case.Corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: INSORB
• Common Device Name: SKIN STAPLER/STAPLE, BIOABSORBABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 -135
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 -135
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611--135 ; 4752651582
• MDR Report Key: 24688644
• Report Number: 1216677-2026-00024
• Device Sequence Number: 15963069
• Product Code: GDW
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/04/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Race: White