MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB 30 STAPLER; SKIN STAPLER/STAPLE, BIOABSORBABLE

Model Number 2030

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that the stapler would not deploy staples.Not additional information is available.No adverse event reported.2030 insorb stapler 2023-06-0000649.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Distribution history the complaint product was manufactured at csi on january 19th, 2022 under work order (b)(4).Manufacturing record review dhr of lot 619005326 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history related to "not firing" shows 16 similar reported complaints including the one under investigation.None of the complaints reviewed were confirmed.Product receipt the complaint product was returned and reviewed by quality engineer, details will be provided on visual and functional evaluation sections.Visual evaluation visual evaluation of the complaint was performed, the stapler was close to 10 staplers loaded.The unit was carefully disassembled, and the staples were found stuck inside the staples chamber of the handle shell right.When taking the staples outside the chamber, this units looks yellowish and adhered between them.Measurement of the staple length was found bellow specification as one unit was found with a value of 0.18435 in and the specification is between 0.186 in to 0.0190 in, this indicates that probably the unit was presenting degradation.Functional evaluation evaluation of the complaint product was performed; the unit was not delivering staples when pulling the trigger of the stapler.Root cause the root cause of this event is related to material as the staples get stuck inside the staples chamber of the handle shell right due to degradation of the staple.

Event Description

No additional information is available.

• Brand Name: INSORB 30 STAPLER
• Type of Device: SKIN STAPLER/STAPLE, BIOABSORBABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651582
• MDR Report Key: 17261214
• MDR Text Key: 318713848
• Report Number: 1216677-2023-00099
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 619005326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1