MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*CUTTER RELOAD UNIT; STAPLE, IMPLANTABLE

Model Number TCR75

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #t5af99.The following information was requested, but unavailable: can you please clarify how the tcr75 reload presented a "defect"? was the device that had this reload loaded not fire (no staples or cut line delivered)? or was the device only partially fired (staple line and cut line were only partially delivered)? please provide further detail of the event.Response: the distributor informed that they don't have additional information about this case.Product investigation summary the analysis results found that the tcr75 reload was received with the forks damaged, four drivers up along the cartridge and the swing tab was noted to be missing, making the reload nonfunctional.No functional test was performed due to the condition of the reload.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.The damage in the forks and missing swing tab are consistent with an improper loading technique.It should be noted that 100% inspection is performed by means of an automated vision system to insure staples are present, and the swing tab is present and unlocked.

Event Description

It was reported that during a right colectomy, the load presented a defect.Per medical report: "patient undergoing right colectomy with linear stapler + 4 loads 75 mm.Note: one (01) stapler load was observed product was inadequate (defect in one of the loads), so 04 loads were used in the procedure." the patient did not have any permanent damage, did not need to be hospitalized or had to be lengthened due to product problems, did not need to be reoperated or had any serious damage.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9674219
• MDR Text Key: 203855195
• Report Number: 3005075853-2020-00792
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013136
• UDI-Public: 10705036013136
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: TCR75
• Device Catalogue Number: TCR75
• Device Lot Number: T40210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1