MAUDE Adverse Event Report: TELEFLEX MEDICAL VCLUDE APLR MED CVD 8" 203MM; APPLIER, SURGICAL, CLIP

Model Number	IPN055313
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Having issues with clips sticking in the jaws after being closed.The clip did not fall in the patient.
Additional Manufacturer Narrative
Qn#: (b)(4).The device investigation is pending.
Additional Manufacturer Narrative
(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 70482.(1) sample of 70482 lot#18110001 was received for evaluation.This sample is also referenced in tc# 20043078 and tc# 20043105.The referenced failures are all different observations of the same failure.Visual review noted that the jaws are not aligned when closed.Wear marks on the jaws were also noted.No service dates were noted on the instrument and this device requires routine service based on usage (average 3-6 months).The functional failures noted should have initiated a periodic servicing.A functional inspection noted excessive play in the boxlock region which allows the jaws to scissor.This scissoring action has scraped the edges of the jaws and created sharp edges.Manufacturing of this device has been discontinued.(1) sample of 70482 lot#18110001 was received for evaluation.This sample is also referenced in tc# 20043078 and tc# 20043105.The referenced failures are all different observations of the same failure.Visual review noted that the jaws are not aligned when closed.Wear marks on the jaws were also noted.No service dates were noted on the instrument and this device requires routine service based on usage (average 3-6 months).The functional failures noted should have initiated a periodic servicing.A dimensional inspection was not required as part of this investigation.A functional inspection noted excessive play in the boxlock region which allows the jaws to scissor.This scissoring action has scraped the edges of the jaws and created sharp edges.2 additional complaints were generated from this single device.Reference tc# 20043078 and tc# 20043105.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 70482.
Event or Problem Description
Having issues with clips sticking in the jaws after being closed.The clip did not fall in the patient.

• Brand Name: VCLUDE APLR MED CVD 8" 203MM
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14934228
• Report Number: 3011137372-2022-00125
• Device Sequence Number: 17574936
• Product Code: GDO
• UDI-Device Identifier: 24026704667073
• UDI-Public: 24026704667073
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN055313
• Device Catalogue Number: 70482
• Device Lot Number: 18110001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown