MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problems Break (1069); Ejection Problem (4009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during a laparoscopic low anterior resection, the second clip was slanted when loaded into the jaws, a clip fell, the jaws would not fully open, and a clip broke.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35w 6/box lot # 73m1700228 was manufactured on 12/12/2017 a total of 9,000 pieces.Lot was released on 12/30/02017.Dhr investigation did not show issues related to complaint.The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned sample revealed that the device was returned with its trigger partially engaged and with an incorrectly formed staple unable to release from the device.The staples appeared to be misaligned.The stapler was returned with 31 staples left in the cover block including the incorrectly formed staple indicating that at least 4 staples have been fired by the end user.First, the trigger cycle was completed and the incorrectly formed staple was able to release from the device.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.No staples fired.The trigger was engaged two more times with no staples firing.The misalignment of the staples is preventing the staples from moving down the track and into the forming tool.An attempt to manually realign the staples was made.However, the staples were unable to realign.The stapler was disassembled and it was confirmed to have been assembled correctly.The remaining staples were removed from the cover block.A microscopic examination of the staple tips was performed with no burrs or defects observed.No other defects or anomalies were observed.It could not be determined what caused the staples to misalign.The ifu for this product, l03485, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple c losure, the trigger must be squeezed all the way in." a corrective action is not required at this time as it cannot be determined what caused the staples to misalign.No errors could be found in the assembly to suggest a manufacturing related cause.All staplers are 100% inspected at manufacturing for firing at the time of assembly.The potential cause of this complaint issue could not be determined.The reported complaint of "jamming" was confirmed based upon the sample received.The staples in the returned stapler are misaligned which is preventing the staples from moving down the track into the forming tool.All staplers are 100% inspected at manufacturing for firing at the time of assembly.It cannot be determined what caused the staples to misalign.No errors could be found in the assembly.Therefore, the potential cause of this complaint issue could not be determined.

Event Description

It was reported that during a laparoscopic low anterior resection, the second clip was slanted when loaded into the jaws, a clip fell, the jaws would not fully open, and a clip broke.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8227615
• MDR Text Key: 132414674
• Report Number: 3003898360-2019-00040
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• 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: 12/17/2018

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 Expiration Date: 07/10/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1800294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1