MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIAMAX; STAPLE, IMPLANTABLE

Model Number GIA8038RL

Device Problems Unsealed Device Packaging (1444); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic hemicolectomy procedure, the surgeon was able to press the green button and squeeze the handle but device misfired and there was poor staple formation and the staple line was incomplete.The case was converted into an open procedure and used an open stapler to complete the case.The firing knob of the open stapler broke and the stapler partially fired.The staple line was resected and re-stapled.It was also noted that there was an issue with the seal of the packaging of the open stapler.A new device was used to resolve the issue and complete the case.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two photographs and one device.Visual and photographic inspection of the cartridge noted that the loading unit was partially applied and the interlock was engaged with no knife blade damage.The firing knob was disengaged from the single use loading unit (sulu).Additionally, cracks were noted on the surface of the loading unit.Functional evaluation of the loading unit was precluded due to the disengaged firing knob.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the detached firing knob condition may occur if an excessive upwards force is applied to the firing knob during disassembly, or if the knob is not fully rotated to one side prior to firing, causing detachment.Replication of the partial firing and cracks on the surface of the sulu condition may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.If the firing knob is not fully re tracted, difficulty in unloading the loading unit may be experienced, and may prevent further loading from occurring.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIAMAX
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9545375
• MDR Text Key: 173530619
• Report Number: 1219930-2020-00079
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521168630
• UDI-Public: 20884521168630
• Combination Product (y/n): N
• PMA/PMN Number: K122781
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: GIA8038RL
• Device Catalogue Number: GIA8038RL
• Device Lot Number: N8M0794Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR