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

Model Number TCR75

Device Problems Break (1069); Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5df9g.Device analysis: the analysis results found that the tcr75 reload was received.The cartridge was received unfired with the swing tab in locked position and the forks were noted to be damaged.No functional test was performed due to the condition of the reload.In addition, the package was returned, and the blister damaged at the cartridge fork location was noted.This damaged is consisted with an improper loading technique.Please reference the instruction for use for proper cartridge loading.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown open abdominal procedure, the tab of the reload broke off/cracked at the end of the stapler reload.It was not reported if the reload cracked while loading or during use.It was not reported how the procedure was completed.There were no patient consequences reported.

• 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: 9945221
• MDR Text Key: 199134567
• Report Number: 3005075853-2020-02089
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013136
• UDI-Public: 10705036013136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TCR75
• Device Catalogue Number: TCR75
• Device Lot Number: T40U0X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1