MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported per medwatch uf/importer report# (b)(4).The report states: two hemolok clips were placed distally and proximally.When the second most distal clip was placed, the hemolok applier would not open.Multiple maneuvers were attempted to allow this device to open and all were unsuccessful.Because the applier was locked on the cystic duct, we ultimately placed another clip inferior to the most distal clip, at what appeared to be the junction of the cystic duct and common bile duct.We then divided the cystic duct with scissors just below the hemolok applier and we were able to free the clip applier from the specimen side using shears.There remained only one clip on the cystic duct, although this appeared secure.The malfunctioning instrument was passed off the field and marked for repair.There was a more posterior branch of the cystic artery identified that was divided successfully with electrocautery.

Manufacturer Narrative

Qn#(b)(4).We are unable to provide a thorough dhr review at this time since lot number information has not been provided on supplied documentation.We are also unable to determine what caused the alleged defect or validate the alleged complaint since the alleged instrument has not been returned for evaluation.All instruments produced at this facility are 100% visually inspected and function tested and lubricated prior to shipment to customer as this is a standardized procedure at this facility for this product line.

Event Description

Reported per medwatch uf/importer report# (b)(4).The report states: two hemolok clips were placed distally and proximally.When the second most distal clip was placed, the hemolok a pplier would not open.Multiple maneuvers were attempted to allow this device to open and all were unsuccessful.Because the applier was locked on the cystic duct, we ultimately placed another clip inferior to the most distal clip, at what appeared to be the junction of the cystic duct and common bile duct.We then divided the cystic duct with scissors just below the hemolok applier and we were able to free the clip applier from the specimen side using shears.There remained only one clip on the cystic duct, although this appeared secure.The malfunctioning instrument was passed off the field and marked for repair.There was a more posterior branch of the cystic artery identified that was divided successfully with electrocautery.

Event Description

Reported per medwatch uf/importer report#(b)(4).The report states: two hemolok clips were placed distally and proximally.When the second most distal clip was placed, the hemolok a pplier would not open.Multiple maneuvers were attempted to allow this device to open and all were unsuccessful.Because the applier was locked on the cystic duct, we ultimately placed another clip inferior to the most distal clip, at what appeared to be the junction of the cystic duct and common bile duct.We then divided the cystic duct with scissors just below the hemolok applier and we were able to free the clip applier from the specimen side using shears.There remained only one clip on the cystic duct, although this appeared secure.The malfunctioning instrument was passed off the field and marked for repair.There was a more posterior branch of the cystic artery identified that was divided successfully with electrocautery.

Manufacturer Narrative

Qn#(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) pc.Lot in (b)(6)2018.Evaluation of the returned instrument shows that the tips are loose and misaligned to each other and the jaw pivot pin is partially pushed thru the outer tube assembly and the outer tube is damaged/bent open thus we are able to validate this complaint.We are unable to determine what caused this instrument to be damaged but mishandling of the returned device at the end user's facility is suspected.All 50 instruments from this lot were 100% visually inspected and function tested and lubricated prior to shipment to customer as this is a standardized procedure at this facility for this product line.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8941773
• MDR Text Key: 155872496
• Report Number: 3011137372-2019-00263
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention