MAUDE Adverse Event Report: STERILMED, INC. MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS; CLIP, IMPLANTABLE, REPROCESSED

Model Number	ETHER320
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that an (b)(6) female patient underwent a laparoscopic cholecystectomy procedure with a reprocessed multi clip applier ligaclip erca rotating medium/large clips and suffered a bile leak.A reprocessed clip applier was opened with 10 clips inside.The surgeon clipped the duct of the gallbladder and when he manipulated the gallbladder the clips fell off, leaking a large amount of bile into the abdomen.The gallbladder was removed quickly, and the gallbladder was extracted.The patient had a drain inserted due to the leakage and surgeon felt like patient needed to be admitted because of the leakage.The patient was admitted to hospital for overnight monitoring and has fully recovered.
Additional Manufacturer Narrative
It was reported that an 85-year-old female patient underwent a laparoscopic cholecystectomy procedure with a reprocessed multi clip applier ligaclip erca rotating medium/large clips and suffered a bile leak.The surgeon clipped the duct of the gallbladder and when he manipulated the gallbladder the clips fell off, leaking a large amount of bile into the abdomen.No device was returned for a full investigation therefore no determination of possible contributing factors could be made.Should the device be received in the future, the investigation may be reopened at that time.A manufacturing record evaluation was performed, and no discrepancies noted, or no non-conformances identified.In addition, a user facility (4600150000-2019-8018) of this event was received.Therefore, b2 (required intervention) and e4 (reporter also sent to fda) fields were updated.Manufacturer's ref.No: (b)(4).

• Brand Name: MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 9512311
• Report Number: 2134070-2019-00152
• Device Sequence Number: 2703035
• Product Code: NMJ
• UDI-Device Identifier: 10888551018937
• UDI-Public: 10888551018937
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K033579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2020
• Device Model Number: ETHER320
• Device Catalogue Number: ETHER320
• Device Lot Number: 2105722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 89