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	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot #: 619064921 or 619064917.Device was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a cesarean section delivery on (b)(6), 2025.The insorb stapler was used for surgical site closure.The provider stated no complications/concerns while using the device in surgery.Roughly 5-6 hours post-op the incision had opened and patient required additional surgery to repair.Provider feels this was due to a malfunction in the device.Two devices were opened, but unsure which device was used.Both were discarded.No additional information was provided.1216677-2026-00005 2030, insorb 2026-01-0000376.
Additional Manufacturer Narrative
Updated: a2, a4, a6, b4, d4, e3, e4, g2, g3, g6, h2, h3, h11.Updated with medwatch information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured by csi on 07/30/2025.Manufacturing record review: dhr was reviewed and no nonconformities related to the complaint condition were noted.The quality system investigation smartsheet was reviewed and no ncmrs were found for this lot number.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint wound separation is reported.However, in those cases, no further information was provided and no evidence to confirm the complaint was found.Product receipt: the complaint product was not returned to 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: a definitive root cause for this issue could not be determined.Details regarding the specific surgery, procedural steps, and the physician's technique and level of proficiency are unknown.The ifu outlines the proper closure technique and provides considerations intended to minimize superficial or external staple placement; however, the post-operative care performed in this case is also unknown.Wound separation is listed as a potential adverse reaction in the ifu.Additionally, the manufacturing records for the staples included in this stapler lot were reviewed, and no nonconformities were identified.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.
Event or Problem Description
No additional information.

• Brand Name: INSORB
• Common Device Name: SKIN STAPLER/STAPLE, BIOABSORBABLE
• 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: 24213486
• Report Number: 1216677-2026-00005
• Device Sequence Number: 9385373
• Product Code: QQS
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104(10)619064921
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 619064921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 03/19/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: American Indian Or Alaskan Native