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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location is unknown.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 caesarean section on an unknown date.At some point, post surgery, the surgical site partially re-opened.Attempts have been made, but no additional information has been provided.(b)(4).
Additional Manufacturer Narrative
Updated: distribution history the complaint product was manufactured by csi on 7/11/2024.Manufacturing record review dhr was reviewed and no nonconformities related to the complaint condition were noted.Incoming inspection review incoming inspection record review not applicable to this product.Historical complaint review a review of the 2-year complaint history showed few cases of similar conditions in which the patient opened after surgery.However, those cases were unconfirmed as no objective evidence was provided and postoperative care was also unknown.Product receipt the complaint product was not returned to csi.The complaint was received via phone call and the customer indicated the product was not available.Visual 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 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.Any relevent customer or clinical information procedure: c-section.Root cause no definitive root cause for this issue could be reliably determined, as no product was sent for evaluation however, according to (b)(4) issued by the same customer, same lot number and same procedure, in that case the returned product tested to specifications.It's worth mentioning that the details about the surgery and the procedure are unknown as also the proficiency and technique from the physician performing the procedure.The ifu demonstrates the proper closure technique and mentions the considerations in order to minimize superficial or external staple placements, the post-operative care followed is also unknown.Wound separation is a potential adverse reaction as indicated in the ifu.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: 21874784
• Report Number: 1216677-2025-00018
• Device Sequence Number: 12737557
• Product Code: GDW
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104(10)619044400
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 619044400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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: Female