MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 8886848813

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Tissue Damage (2104); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, postoperative to a laparoscopic cholecystectomy, clips fell into the cavity, which were retrieved through the trocar.Tissue damage was observed.There was leakage at the cystic duct.The event led to cystic insufficiency.Laparoscopic reoperation was required.

Manufacturer Narrative

Additional information: b2 (date of birth), g4.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.

Manufacturer Narrative

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.

Event Description

According to the reporter, postoperative to a laparoscopic cholecystectomy, the patient went to another hospital due to pain in the abdomen where diagnostics were done.It was found that clips fell into the cavity, which were retrieved through the trocar.Tissue damage was observed.There was leakage at the cystic duct.The pain in the abdomen because of the leakage.The event led to cystic insufficiency.Laparoscopic reoperation was required.

Manufacturer Narrative

Additional information: d8, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the first photo depicts a clip which appears to be properly applied.The second photo depicts an additional clip applied next to the first clip, appears properly applied.The third photo a clip body broken in two pieces at the apex of the body.It was reported that the clip did not hold tightly to the vessel and detached.Also, a component disengaged from the device.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAPRO-CLIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10661112
• MDR Text Key: 211002848
• Report Number: 1219930-2020-04201
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• Combination Product (y/n): N
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

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 Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N0G1035Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 11/19/2020; 12/21/2020
• Supplement Dates FDA Received: 10/29/2020; 12/10/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 68