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

Model Number 783100

Device Problem Failure To Adhere Or Bond (1031)

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, orthopaedic surgeon found that the staples could not stay in skin.The staples dropped out from skin.

Manufacturer Narrative

Samples received: 2 open and used staplers.Analysis and results: there are two previous complaints of the same code-batch.There are no units in our stock.We have received two open and used samples that have been analyzed: 1) visual inspection if the returned staplers: stapler 1: 17 staples were left inside the cartridge and not uniform.Blood was adhered on the components of the cartridge.Some scratches were observed on the surface of the cartridge.The latch of the cartridge was not hooked correctly.Stapler 2: 17 staples were left inside the cartridge and not uniform.Blood was adhered on the components of the cartridge.Some scratches were observed on the surface of the cartridge.The latch of the cartridge was not hooked correctly.2) reproducibility test - staple release test of the returned staplers: 2.1) stapling release test with the returned staplers before disassembling: stapler 1: remaining 17 staples were released without any problem.Reproducibility was not observed.Stapler 2: remaining 17 staples were released without any problem.Reproducibility was not observed.2.2) stapling release test with the returned staplers after re-assembling and reloaded 36 staples (test was conducted twice): stapler 1: the 5ft staple was not released properly in the first test.Reproducibility was observed.However, after replacing damaged components such as anvil and ram, all the staples, 36 units were released properly.Stapler 2 all the staples, 36 were released properly and stapling function worked without any problems.Reproducibility was not observed.3) disassembled components check of the two used staplers: stapler 1: no problem was found with the measured values of each component of the sample stapler 1.Left side groove of the ram was deformed.Both corners of the anvil were worn.Stapler 2: no problem was found with the measured values of each component of the stapler 2.Left side groove of the ram was deformed.Both corners of the anvil were worn.As the results of the investigation, no problem was found with the production record or measured values of each component of the returned staplers.Unhooked latch and damaged components such as anvil and ram was observed with both staplers and reproducibility was observed with the stapler 1.However, when the damaged components were replaced and latches were hooked properly, stapling function worked properly.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: 7597069
• MDR Text Key: 111016768
• Report Number: 3003639970-2018-00354
• 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

• 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: U178031300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2018
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other