MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number UNKNOWN ENDO CLIP APPLIER

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemostasis (1895); Pain (1994); No Code Available (3191)

Event Date 10/02/2019

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, the patient with general anesthesia downlink laparoscopic cholecystectomy, intraoperative use of absorbable clip off the gallbladder artery ligation, cystic duct, cause abdominal pain, after checking the patient lesser omentum sac drainage tube led to bloody fluid 137 milliliter, an immediate hemostatic treatment, then checked the lesser omentum sac drainage tube was still active bleeding, after communicated with the patient and family members to inform considering the gallbladder artery ligation can be absorbed clip off bleeding, laparoscopic exploration should be carried out again to stop bleeding, intraoperative it was found the absorbable ligature clip behind cystic artery fell off, then two absorbable ligature clips were used.

• Brand Name: UNKNOWN ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9286374
• MDR Text Key: 165310779
• Report Number: 1219930-2019-06238
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO CLIP APPLIER
• Device Catalogue Number: UNKNOWN ENDO CLIP APPLIER
• Device Lot Number: N7K0470X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR