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

Model Number	GIA8038RL
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Detachment of Device or Device Component (2907); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hemicolectomy with total abdominal hysterectomy and salpingo oophorectomy, after opening the sterile packaging, yellow shipping wedge was already removed without even removing it manually.When applied on the anastomosis, the firing knob broke for the white flag interlock already engaged.It was also reported that device partially fired and had poor staple formation which staples got dismantled.Misfired staples fell into the patient cavity.Surgeon oversewed to fix the staple line.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph and three devices.Three loading units were received.The first loading unit was received partially applied with the interlock engaged and the knife blade was advanced.The second loading unit was received with a full complement of staples and the interlock was engaged.Additionally, the firing knob was detached for both loading units.The third loading unit was received with a full complement of staples and the interlock was engaged.Functional testing of the first and second loading unit was precluded due to the detached firing knobs.The third loading unit was reset and loaded into a test instrument for functional testing.The instrument and loading unit were applied to the appropriate test media with acceptable results.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 partial firing 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 retracted, difficulty in unloading the loading unit may be experienced, and may prevent further loading from occurring.Replication of the disengaged 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 engaged interlock condition may occur as a result due to improper loading of the cartridge.The root cause of the observed damage was found to be due to the device 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.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of two devices.The visual inspection the returned photograph noted two loading units.It was noted in the photograph that both firing knobs loading were detached.The first loading unit was partially applied and the interlock was engaged.Additionally, the knife blade was advanced.The second loading unit displayed a full complement of staples and the interlock was engaged.Functional testing was precluded since the loading units were not received.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 partial firing 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 retracted, difficulty in unloading the loading unit may be experienced, and may prevent further loading from occurring.Replication of the disengaged 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 engaged interlock condition may occur as a result due to improper loading of the cartridge.The root cause of the observed damage was found to be due to the device 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
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9335023
• Report Number: 1219930-2019-06412
• Device Sequence Number: 16626132
• Product Code: GDW
• UDI-Device Identifier: 20884521168630
• UDI-Public: 20884521168630
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K122781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: GIA8038RL
• Device Catalogue Number: GIA8038RL
• Device Lot Number: N8F0561X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/27/2020; 02/27/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/28/2020; 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention