MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB 30 STAPLER

Model Number 2020

Device Problems Noise, Audible (3273); Ejection Problem (4009)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

(b)(4).Dr.(b)(6) went to use this product to close the c-section skin layer.When she squeezed to activate the stapler it made a strange noise and ejected all the staples at once into the wound which had to be retrieved.12/10/2020- follow-up response stated: there was a delay in closing the incision, staples required removal from the abdominal cavity then a new stapler was utilized to close the incision.Was there any fragment left in patient during this procedure? it did not appear so.Did the physician perform any extra steps to complete the procedure? yes, retrieval of the expulsed staples and then utilization of a second stapler.Insorb 30 stapler 2030 (b)(4).

Manufacturer Narrative

Investigation initiated manufacturer's investigation no sample returned review dhr *analysis and findings distribution history the complaint product was packaged at csi 4/29/2020.Manufacturing record review lot 201201 was built into csi work order (b)(4).Dhr-2030 - 289993 was reviewed and no non-conformities, related to the complaint condition were noted.It should also be noted that work order (b)(4) was post sterilization sampled by qa for visual and functional attributes where no issues were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history showed did showed similar reported complaint conditions.Product receipt the complaint product was not received, no rma was given.Visual evaluation visual evaluation of the complaint product was not performed as the complaint sample was not returned.If product is returned at a later time, it may be evaluated as needed.Functional evaluation functional evaluation of the complaint product was not performed as the complaint sample was not returned.If product is returned at a later time, it may be evaluated as needed.Root cause a definitive root cause cannot be reliably determined at this time.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.*was the complaint confirmed? no.

Event Description

Doctor went to use this product to close the c-section skin layer.When she squeezed to activate the stapler it made a strange noise and ejected all the staples at once into the wound which had to be retrieved.There was a delay in closing the incision, staples required removal from the abdominal cavity then a new stapler was utilized to close the incision.Was there any fragment left in patient during this procedure? it did not appear so.Did the physician perform any extra steps to complete the procedure? yes, retrieval of the expulsed staples and then utilization of a second stapler.1216677-2020-00299-1 insorb 30 stapler 2030 (b)(4).

• Brand Name: INSORB 30 STAPLER
• Type of Device: INSORB 30 STAPLER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11003146
• MDR Text Key: 249927565
• Report Number: 1216677-2020-00299
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 00867516000104
• UDI-Public: 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 2020
• Device Catalogue Number: 2030
• Device Lot Number: 201201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Life Threatening