TPLC - Total Product Life Cycle

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Device	forceps, biopsy, non-electric
Regulation Description	Gastroenterology-urology biopsy instrument.
Product Code	FCL
Regulation Number	876.1075
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Open or Close	93	93
Adverse Event Without Identified Device or Use Problem	89	89
Failure to Cut	22	22
Dull, Blunt	20	20
Device Contamination with Chemical or Other Material	18	18
Break	18	18
Mechanical Problem	15	15
Material Twisted/Bent	14	14
Use of Device Problem	12	12
Insufficient Device Problem Information	9	9
Human-Device Interface Problem	8	8
Device Contaminated During Manufacture or Shipping	8	8
Device Reprocessing Problem	7	7
Entrapment of Device	6	6
Difficult to Advance	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Difficult to Remove	6	6
Material Integrity Problem	6	6
Delivered as Unsterile Product	5	5
Detachment of Device or Device Component	4	4
Physical Resistance/Sticking	4	4
Device Damaged Prior to Receipt by User	3	3
Contamination	3	3
Mechanical Jam	3	3
Device Damaged Prior to Use	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Failure to Clean Adequately	2	2
Material Deformation	2	2
Residue After Decontamination	2	2
Unsealed Device Packaging	2	2
Retraction Problem	1	1
Stretched	1	1
Loose or Intermittent Connection	1	1
Structural Problem	1	1
Fracture	1	1
Wrong Label	1	1
Failure to Obtain Sample	1	1
Difficult to Insert	1	1
No Apparent Adverse Event	1	1
Improper or Incorrect Procedure or Method	1	1
Product Quality Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	203
Hemorrhage/Blood Loss/Bleeding	49	49
No Known Impact Or Consequence To Patient	39	39
No Consequences Or Impact To Patient	29	29
Insufficient Information	20	20
Pancreatitis	16	16
Unspecified Tissue Injury	13	13
Hematoma	10	10
Tissue Damage	10	10
Perforation	9	9
Unspecified Hepatic or Biliary Problem	9	9
Foreign Body In Patient	8	8
Blood Loss	7	7
Laceration(s)	6	6
Hematuria	6	6
No Patient Involvement	5	5
Pneumothorax	5	5
Excessive Tear Production	4	4
Cholangitis	4	4
Urinary Tract Infection	3	3
Inflammation	3	3
Renal Failure	3	3
Sepsis	3	3
Dysuria	3	3
Gastrointestinal Hemorrhage	3	3
Tachycardia	3	3
No Code Available	3	3
Fever	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Information	2	2
Septic Shock	2	2
Pneumonia	2	2
Hypovolemic Shock	2	2
Respiratory Failure	2	2
Urinary Retention	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Death	2	2
Liver Failure	2	2
Abdominal Pain	2	2
Device Embedded In Tissue or Plaque	2	2
Dyspnea	2	2
Vomiting	2	2
Fistula	2	2
Angina	1	1
Micturition Urgency	1	1
Urinary Incontinence	1	1
Air Embolism	1	1
Heart Failure/Congestive Heart Failure	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Hematemesis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jul-31-2026
2	Richard Wolf GmbH	II	Apr-24-2023