MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER ML 8" CVD; APPLIER, SURGICAL, CLIP

Model Number	IPN914973
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Alleged issue: informally in surgery rooms they inform me that the clips did not close since the clamp was not in good condition.The clips have been used without any problem with other clamps.I have not received a formal quality report from the institution.The clamp was removed and the applier is available to be shipped physically.Medical intervention was necessary but patient is fine, no patient harmed was reported.I do not have more details, the client does not have additional information.
Additional Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.It was also found that this order was made from the correct materials and components.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) lot in april of 2018.Evaluation of the returned instrument shows that it has additional laser marking of a dot matrix coding on its handle stem next to the horizon logo , which is not performed at this facility at this time.Function testing as performed at time of production was performed and this instrument is able to pick-up, retain, close and release multiple clips without any issues noted.6 closed clips were measured , and they were all within the tolerance specification or.0114 max gap for leg gap@.005,.0057,.0058,.0062,.0063,.0062 and.0143 max.Gap for eye gap @.0021,.0024 ,.0025,.0022,.0024.We are unable to validate this complaint since we were unable to replicate the alleged issue.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings , no further actions will be taken in response to this complaint and this record will be deemed closed.
Event or Problem Description
Alleged issue: informally in surgery rooms they inform me that the clips did not close since the clamp was not in good condition.The clips have been used without any problem with other clamps.I have not received a formal quality report from the institution.The clamp was removed and the applier is available to be shipped physically.Medical intervention was necessary but patient is fine, no patient harmed was reported.I do not have more details, the client does not have additional information.

• Brand Name: HZ APPLIER ML 8" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12245102
• Report Number: 3011137372-2021-00210
• Device Sequence Number: 3223058
• Product Code: GDO
• UDI-Device Identifier: 24026704710137
• UDI-Public: 24026704710137
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: IPN914973
• Device Catalogue Number: 337081
• Device Lot Number: 06F1752527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention