MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN

Catalog Number SURGICAL UNKNOWN

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Pain (1994); Blood Loss (2597)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient claims that following a laparoscopic partial nephrectomy in which hem-o-lok clips were used, he experienced complications including clip migration and the expulsion of a clip during urination, clip breakage, inflammation, bleeding, and pain.The patient further states that he later underwent a radical nephrectomy in order to resolve such complications.

Manufacturer Narrative

(b)(4).Dhr review could not be conducted since the lot number was not provided.P/n was not provided, however, a part number from the family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 20 samples were taken from the current production p/n 544240 hemolok l clips 6/cart 84/box, lot# 73a1800417, samples were functionally inspected, and during the test, issue reported "clip migrated" was not observed in the current manufacturing process.The ifu l03507 for this products was reviewed as a part of this complaint investigation.The ifu states "contraindications hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies." corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the other remarks: product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

Patient claims that following a laparoscopic partial nephrectomy in which hem-o-lok clips were used, he experienced complications including clip migration and the expulsion of a clip during urination, clip breakage, inflammation, bleeding, and pain.The patient further states that he later underwent a radical nephrectomy in order to resolve such complications.

• Brand Name: SURGICAL UNKNOWN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7212427
• MDR Text Key: 97986866
• Report Number: 3003898360-2018-00040
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention