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 06/19/2023

Event Type  malfunction  

Event Description

It was reported that the staplers deliver staples that crack in half upon trigger pull inside patient.The product was disposed of as biohazard.No adverse event was reported.No additional information is available.2030 insorb stapler 2023-06-0000481.

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 october 13th, 2022 under work order: (b)(4).Manufacturing record review: dhr of lot: 619016292 was reviewed and no non-conformities, related to the complaint condition, were noted.The lot was on non-conformity ncmr-2022-10-0120, however it was for the handle slot width out of spec, and it is not related to this event.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 did show similar reported complaint conditions.This is an isolated event.Product receipt: the complaint product was not returned.Visual evaluation: visual evaluation of the complaint could not be performed as no sample was received and no pictures of the unit were sent.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: no definitive root cause for this issue could be reliably determined at this time because the product was not returned for evaluation.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

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: 17286938
• MDR Text Key: 318668572
• Report Number: 1216677-2023-00100
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 867516000104
• UDI-Public: (01)867516000104
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 619016292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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