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	01/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unknown surgery where the insorb stapler was used for the first time during a head and neck free flap case.The wound dehisced several hours after the case while the patient was recovering at the hospital.The wound was sutured back up.The dehiscence was around the midpoint of the wound, which was where most of the tension was dispersed.The head & neck resident that closured this fibula free flap donor site, used the proper wound closure layering (scarpa's facia with suture, insorb for deep dermal, and then subcuticular closure with suture); although insorb was used starting on both sides of the wound and ended in the midpoint, where a stitch had been be placed since the nose of the stapler couldn't fit for the last staple.No additional information was available.(b)(4).
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.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.A consultation was conducted with medical affairs to determine whether the technique utilized was appropriate.Medical affairs clarified that the ifu does not specify any limitations regarding closing the wound from the ends toward the center.However, they emphasized that adequate space must be maintained to allow the stapler to invert properly and facilitate placement of the final staple.The use of a supporting suture may contribute to wound separation; and this cannot be attributed to the use of the insorb stapler.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 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: 24203487
• Report Number: 1216677-2026-00004
• Device Sequence Number: 14836290
• Product Code: QQS
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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
• Patient Sex: Unknown