MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MANIPLER AZ - 35W SKINSTAPLER; SKIN STAPLER, TEXTILE SKIN CLOSURE

Model Number 783100

Device Problems Mechanical Problem (1384); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Source: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Exempt.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there was an issue with manipler skin stapler.The client reported that the manipler skin stapler does not staple properly.No further data has been provided.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 2,400 units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received 1 open and 11 closed samples to analyze this complaint.1 opened stapler and 3 unopened staplers (randomly chosen) have been analyzed: 1) production record sheet check: components record sheet: -no abnormalities were found in the record sheet.2) visual inspection of the returned staplers (1 opened stapler and unopened staplers): - no problems were found with the returned staplers by visual inspection.- concerning the opened stapler, there were still 31 staples inside the cartridge.- all the components were assembled correctly.- all the staples were loaded in line in cartridge correctly.3) reproducibility test of the returned staplers (1 opened stapler and 3 unopened staplers): - all the staples were released without any problems.Staple function worked properly.- reproducibility was not observed by the returned staplers.4) disassembled components check: -no problem was found with the measured values of each component.-no problem was found with the shape of each component.As the result of the investigation, no problem was found with the production record or measured values of each component of the analyzed staplers.All the staples of the analyzed samples were released without any problems in reproducibility test.Staple function worked properly.We are not able to continue further investigation without the stapler actually used.Final conclusion: although the results of the samples received fulfil the specifications we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.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, TEXTILE SKIN CLOSURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10990380
• MDR Text Key: 220883855
• Report Number: 3003639970-2020-00461
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): Y
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 783100
• Device Catalogue Number: 783100
• Device Lot Number: U208027900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1