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	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is being returned for investigation.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.At some point, the surgical site re-opened.Attempts have been made, but no additional information has been provided.(b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h11.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.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions where the staplers erupted after surgery.However, there have been cases were wound separation is reported.Product receipt: the complaint product was received (1 closed stapler) on 4/4/2025.Visual evaluation: visual evaluation revealed no physical damage.The product was received sealed.Functional evaluation: the returned product was functionally evaluated.The stapler was completely emptied of staples which were successfully deployed.The staples were measured and passed.Any relevent customer or clinical information: procedure c-section.Root cause: no definitive root cause for this issue could be reliably determined, the returned product tested to specifications.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 listed in the adverse reactions section of the ifu.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 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: 21874783
• Report Number: 1216677-2025-00017
• Device Sequence Number: 15428670
• 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): 06/03/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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