MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number CL-884

Device Problems Break (1069); Dull, Blunt (2407); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic total hysterectomy, while suturing the vaginal stump, the needle became blunt.After removing the needle, it was found that the tip of the needle was damaged.The hand-washing nurse found the needle defected during the needle examination, and immediately informed the circuit nurse.The two nurses confirmed and kept the certificate and immediately informed the radiology department to take the emergency x-ray.After taking the film, the radiologist found a bright spot near the left iliac fossa, which was suspected to be needle tip residue.After that, the surgeon searched and washed the abdominal cavity under the direct vision of laparoscopy.Took another film and found that there were still bright spots in the similar position near the left iliac fossa.The radiologist suggested to change the body position, moved the position of the towel, and then took the film again in the same position but still existed highlights.Radiologists was not sure if it was the needle residue or bone calcification.Another suture was used to complete the case.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of five images of one device.Photographic inspection of the images received noted one suture and one needle attached.Photographic inspection of the needle noted the tip was damaged.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8756279
• MDR Text Key: 149912863
• Report Number: 1219930-2019-03927
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10884521042780
• UDI-Public: 10884521042780
• Combination Product (y/n): N
• PMA/PMN Number: K963253
• 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: 08/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: CL-884
• Device Catalogue Number: CL-884
• Device Lot Number: A7L1101X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention