MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MANIPLER AZ - 35W SKINSTAPLER; SKIN STAPLER

Model Number 783100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).After firing, surgeon found that the staples could not stay in tissue (skin).The staples just dropped out from skin.

Manufacturer Narrative

Samples received: 1 open and used staplers.Analysis and results: there is a previous complaint of the same code-batch.There are no units in our stock.We have received one open and used sample that has been analysed: 1) visual inspection if the returned stapler: - one staple was inside the cartridge.- the latch and spring hook were hooked properly.- a lot of blood was adhered on the product.2) disassembled components check of the returned staplers: - no problem was found with the measured values of each component of the returned stapler.- left side groove of the ram was deformed.- both corners of the anvil were worn.3) reproducibility test - stapler release test of the returned stapler: 3.1) stapling release test with the returned stapler before disassembling: - the one staple remaining inside the cartridge was released properly.3.2) stapling release test after disassembling and re-assembling the stapler with all the same components: - reproducibility was observed with the returned stapler re-assembling the same components.Deformed staples were released.3.3) stapling release test after re-assembling the stapler with new anvil and ram - reproducibility was not observed with the returned stapler replacing two components, new anvil and ram.As the results of the investigation, no problem was found with the production record or measured values of each component of the returned staplers.Rounded corners of anvil and deformed groove on ram were observed with the returned stapler.It is highly probable that an unexpected overload of pressure was applied to the products during application and some of the components were damaged causing the malfunctioning under unexpected situation.Final conclusion: although reproducibility was observed with the returned stapler, it is highly probable that an unexpected overload of pressure was applied during application causing the malfunctioning under unexpected situation.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: MANIPLER AZ - 35W SKINSTAPLER
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7560614
• MDR Text Key: 109798245
• Report Number: 3003639970-2018-00346
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 783100
• Device Catalogue Number: 783100
• Device Lot Number: U178031300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2018
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other