MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST BLUE RELOAD, 45MM, 6 ROW; STAPLE, IMPLANTABLE

Model Number GST45B

Device Problems Unintended Ejection (1234); Material Integrity Problem (2978)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were there any patient consequence related to this event? if yes please describe.Does the fragments were retrieved from patient body? investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.

Event Description

It was reported that during a procedure, left the reload after the shooting.It was loose in the abdominal cavity in one of the shots to make the gastric bag during a bypass.It was searched in the abdominal cavity and found in an intestinal loop, after the scrub nurse had noticed that the reload was damaged.No patient consequences reported.No further information is available.

• Brand Name: GST BLUE RELOAD, 45MM, 6 ROW
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15681644
• MDR Text Key: 306792880
• Report Number: 3005075853-2022-07310
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014881
• UDI-Public: 10705036014881
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K163454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GST45B
• Device Catalogue Number: GST45B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1